Novel Keratoprosthesis Designs and Implantation Methods

描述（由申请人提供）：目前全世界有1000万人因角膜疾病而失明。虽然角膜移植被认为是治疗角膜失明的成功方法，但由于各种复杂因素，每年进行的角膜移植手术不到10万例。大多数角膜移植手术是在美国和欧洲进行的，那里的供体角膜最容易获得。然而，即使供体角膜可用于移植，仍有许多短期和长期的并发症，可能导致视力下降甚至失明。因此，有必要开发一种好的替代角膜移植的方法。人工角膜替代植入物或角膜假体（Kpro）的发展已经进行了数百年的研究，并在过去的50年中取得了一些成功。然而，基于复杂的植入程序和材料的不兼容性，目前的KPro植入物的实用性有限。我们已经为KPro开发了新的植入方法和设计，这可能有助于解决目前KPro手术的许多问题。在我们为期6个月的I期研究中，我们打算使用我们开发的自动角膜口袋制造设备在体内植入新型KPros。KPros的新特点包括：能够通过3到4毫米的切口注射到8到9毫米的角膜袋中，其前表面经过生物化学工程处理，可以进行上皮化。具体来说，我们计划：开发和测试易于使用的软KPro注射器系统。2。在为期四个月的动物实验中，使用我们的角膜口袋制作装置和植入器确定我们的新型软KPro设计的植入质量和生物相容性。如果我们的研究成功，这可能意味着大多数目前需要角膜移植的角膜疾病患者可能能够接受一种新型的人工角膜。这种新型人工角膜具有视力恢复快、不需要供体角膜组织、无供体相关疾病传播风险、无排斥反应风险等优点。

DESCRIPTION (provided by applicant): Diseases of the cornea currently blind ten million people worldwide. Although corneal transplantation is considered to be a successful treatment for corneal blindness, due to a variety of complicating factors less than 100,000 corneal transplants are performed annually. Most of these corneal transplants are performed in the United States and Europe where donor corneas are most readily available. However, even when a donor cornea is available for transplantation, there are still numerous short term and long term complications which may result in poor visual function or even loss of the eye. For this reason, there is a need to develop a good alternative to corneal transplantation. Development of an artificial corneal replacement implant or Keratoprosthesis (Kpro) has been investigated for hundreds of years and has met with some success over the last 50 years. However, based on complicated implantation procedures and material incompatibilities, current KPro implants have limited utility. We have developed novel methods of implantation and designs for a KPro which may help to solve many of the problems of current KPro surgery. In our 6 month Phase I study we intend to implant novel KPros in vivo using an automated corneal pocket making device that we have developed. The novel characteristics of the KPros include: the ability to be injected into an 8 to 9 mm corneal pocket through a 3 to 4 mm incision and a front surface which has been biochemically engineered to allow epithelialization. Specifically, we plan to: Develop and test the ease of use of a soft KPro injector system. II. Determine the quality of implantation and biocompatibility of our novel soft KPro designs using our corneal pocket-making device and implant injector during a four month animal study If our research is successful, it may mean that the majority of patients with corneal disorders that currently require corneal transplantation may be able to receive a new type of artificial cornea instead. This new type of artificial cornea would have the advantages of a quick visual recovery, no need for donor corneal tissue, no risk of donor related disease transmission, and no risk of rejection.