Artificial Cornea Using New Biomaterials

使用新型生物材料的人工角膜

• 批准号: 7746519
• 负责人: Max Maginness
• 金额: $ 11.64万
• 依托单位: HEALIONICS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7746519
• 关键词: Adhesions; Advanced Development; Affect; Animals; Biocompatible; Biocompatible Materials; Blindness; Boston; Complex; Cornea; Corneal Diseases; Corneal Opacity; Data; Developed Countries; Developing Countries; Development; Devices; Dimensions; Disease; Doctor of Philosophy; Engineering; Epithelial; Evaluation; Eye; Eye Banks; FDA approved; Feasibility Studies; Funding; Glaucoma; Goals; Growth; Healed; Human; Implant; In Vitro; Incidence; Institution; Intraocular lens implant device; Keratoplasty; Laboratories; Laser In Situ Keratomileusis; Lead; Left; Lens (device); Licensing; Light; Mechanics; Medical; Mentors; Methods; Modeling; Modification; Molds; National Eye Institute; One-Step dentin bonding system; Operative Surgical Procedures; Ophthalmology; Optics; Oryctolagus cuniculus; Outcome; Patients; Pattern; Performance; Peripheral; Population; Procedures; Property; Prosthesis; Recovery; Research; Resort; Sclera; Shunt Device; Silicone Elastomers; Silicones; Small Business Technology Transfer Research; Solutions; Structure; Surface; Techniques; Technology; Testing; Time; Tissue Donors; Tissues; Transplantation; Universities; Vision; Visual; Washington; Wound Healing; abstracting; base; biomaterial compatibility; design; follow-up; healing; implantable device; implantation; improved; in vivo; novel; physical property; programs; prototype; public health relevance; regenerative; restoration; scaffold; success; tissue reconstruction

DESCRIPTION (provided by applicant): Artificial Cornea Using New Biomaterials PD/PI Maxwell Maginness PhD Project Summary/Abstract. We propose to advance the development of a novel artificial cornea design enabled by a new biomaterial technology permitting facile integration and sclera tissue reconstruction. The design offers potential for an excellent visual outcome, stable and robust integration with the host tissue; is anticipated to overcome limitations of previous artificial cornea designs and does not require human donor tissue. Early animal studies also suggest that the design allows for a simple surgical implantation technique. The proposal is directed at the National Eye Institute Corneal Diseases Program under the "development of new biomaterials for corneal prostheses" listing. The Medical Problem: Corneal blindness opacification of the transparent tissue covering the front of the eye is one of the two most prevalent causes of treatable blindness. It affects some 12 million people worldwide. [1] Corneal transplants with human donor tissue offer solutions for a fraction of patients with less severe disease, with approximately 100,000 such procedures worldwide every year. These procedures require the support of eye banks, not available in many world regions with a high incidence of blindness. In developed countries increasing numbers of LASIK procedures are rendering many potential donor eyes unusable. [2] The alternative is an artificial cornea (Keratoprothesis "K-pro"). There are two currently available FDA- approved devices - the Boston K-Pro [3] and the AlphaCor device [4]. These show poor integration with host tissue and require complex surgical implantation with lengthy follow-up. Presently they are offered only as a last resort in a few centers nationwide (University of Washington is one of them), leaving many untreated cases. Proposed Solution: Our proposed artificial cornea design aims to overcome these limitations a by combining: A clear, semi rigid optical center, proven to provide excellent and rapid visual recovery A porous periphery based on Spherically Templated Angiogenic Regenerative (STAR) biomaterial structure to rapidly achieve a robust, stable, well-integrated host tissue interface. Use of well proven biocompatible materials (silicones) with appropriate optical and mechanical properties for the entire artificial cornea device structure. No donor tissue required. Simple, one step surgical procedure. Originally developed at the University of Washington Engineered Biomaterials Laboratory under Dr Buddy Ratner, (mentoring this project) STAR [5] is a porous 3D biomaterial with a unique, tightly controlled geometry enhancing tissue attachment, in-growth and revascularization. The structure may be made from a variety of substrate materials, including biocompatible silicone rubbers as already widely used in other ophthalmic devices (e.g. glaucoma shunts, IOL's). Healionics Corporation holds exclusive license and is commercializing forms of the STAR material for a variety of medical applications. Preliminary studies with STAR biomaterial structures in the rabbit sclera have shown the rapid tissue integration and desirable reconstructive, vascularized, afibrotic healing patterns needed for a successful prosthetic cornea. The primary aim of this proposal is to extend and combine the biomaterials capability of Healionics Corporation with the in vitro and in vivo feasibility studies done by Dr. Ratner and Dr. Shen of UW Ophthalmology towards the next steps in developing an artificial cornea. The proposed developments of better construction methods, periphery tissue adhesion studies, durability testing and an extension of in vivo studies, are directed to this goal. The longer term aim is to refine the designs in the light of results obtained under this proposal, proceed to a more extensive study and eventually to human use. Keywords: Artificial cornea, porous biomaterials, treatable blindness, corneal transplant surgery. PUBLIC HEALTH RELEVANCE: Corneal opacity is a major cause of blindness. Use of donor corneas is not applicable for many cases and artificial corneas developed to date have shown serious limitations. The development of a new biomaterial structure with greatly improved sclera tissue integration and excellent optics shows potential to overcome many of these issues and allow construction and application of an improved prosthesis. Success with the steps proposed here may lead eventually to sight restoration covering a much wider population than is possible with present methods.

描述（由申请人提供）：使用新生物材料PD/PI Maxwell Maginness Phd项目摘要/摘要的人造角膜。我们建议通过新的生物材料技术允许便利整合和巩膜组织重建来推动新型人造角膜设计的开发。该设计为与宿主组织的稳定和稳健的整合提供了出色的视觉结果。预计会克服先前人造角膜设计的局限性，并且不需要人类的供体组织。早期动物研究还表明，该设计允许采用简单的手术植入技术。该提案是针对国家眼科研究所角膜疾病计划的，该计划是“针对角膜假体的新生物材料的开发”上市。医疗问题：覆盖眼前的透明组织的角膜失明是造成可治疗失明的两个最普遍的原因之一。它影响了全球约1200万人。 [1]用人体供体组织的角膜移植为疾病较低的患者提供解决方案，全球约有100,000个此类手术。这些程序需要提供眼库的支持，在许多世界地区没有盲目发病率。在发达国家，越来越多的LASIK程序使许多潜在的捐助者眼睛无法使用。 [2]替代方案是人造角膜（角膜假象“ K-Pro”）。当前有两个可用的FDA-批准设备-Boston K-Pro [3]和字母设备[4]。这些显示与宿主组织的整合不佳，需要复杂的手术植入，并进行冗长的随访。目前，它们仅作为全国几个中心的最后一个度假胜地（华盛顿大学就是其中之一）提供，剩下许多未经治疗的案件。提出的解决方案：我们提出的人造角膜设计旨在通过组合来克服这些局限性A：一个清晰的半刚性光学中心，被证明可以提供出色和快速的视觉恢复，一种基于球形模板的血管生成性再生（Star）生物材料结构的多孔外围，以快速，稳定，稳定的，稳定的，良好的，良好的宿主互动。使用经过验证的生物相容性材料（有机硅），具有适当的光学和机械性能，用于整个人造角膜装置结构。无需供体组织。简单，一步手术程序。最初是在华盛顿大学（University of Washington）工程生物材料实验室开发的，该实验室（指导该项目）Star [5]是一种多孔的3D生物材料，具有独特的，紧密控制的几何形状增强的增强组织附件，增长和血运重建。该结构可以由多种底物材料制成，包括已经在其他眼科设备中广泛使用的生物相容性硅胶橡胶（例如青光眼分流器，IOL）。 Healionics Corporation拥有独家许可​​证，并正在商业化各种医疗应用的Star材料的形式。在兔巩膜中使用Star生物材料结构的初步研究表明，成功的假肢角膜所需的快速组织整合和理想的重建，血管化的，可观的愈合模式。该提案的主要目的是将Healionics Corporation的生物材料能力与UW Ophthalmology的Ratner博士和Shen博士进行的体外和体外可行性研究扩展和结合，以开发人工角膜的下一步。提出的更好的施工方法，周围组织粘附研究，耐用性测试和体内研究扩展的拟议发展是针对此目标的。长期的目的是根据本提案获得的结果来完善设计，继续进行更广泛的研究，并最终进行人类使用。关键词：人造角膜，多孔生物材料，可治疗失明，角膜移植手术。 公共卫生相关性：角膜不透明度是失明的主要原因。供体角膜的使用不适用于许多情况，迄今为止开发的人造角膜已显示出严重的局限性。具有大大改善的巩膜组织整合和出色光学元件的新生物材料结构的发展表明了克服许多问题的潜力，并允许建造和应用改进的假体。在这里提出的步骤的成功最终可能导致视力恢复涵盖的人口比目前的方法更广泛。