Development of an Orbital Tissue Expander for Babies

描述(申请人提供)：这个小型企业创新研究第一阶段的项目是开发和测试一种眼眶组织扩张器，可以用于出生时没有眼睛或没有功能的小眼睛的婴儿的眼眶(眼窝)。在这两种情况下，眼眶必须随着婴儿的成长而扩大，以防止面部扭曲和永久性毁容。目前扩大眼眶的手术对婴儿来说是非常痛苦的，需要移除小眼睛，如果有的话，用一个实心的球体取而代之。然后，在患者进入青春期之前，必须用更大的球体至少更换四次实心球体，以确保眼眶与另一只眼睛对称生长。除了对年轻患者造成创伤外，这是一种许多患者家属负担不起的昂贵的外科手术。SBIR项目是开发一种简单的充气球体，称为眼眶组织扩张器，它将固定在眼窝中，用于随着时间的推移扩大轨道。组织扩张器通过简单的针头注射定期用生理盐水充气(如果需要，也可以放气)。与目前的外科技术相比，这种新的设备对患者的创伤要小得多，而且进行顺序扩张的成本也更低。 该装置由一个膨胀的“气球”和一个完整的水凝胶密封组成，使装置能够反复穿透而不会泄漏。该装置将被植入眼眶，用骨板固定到位，然后定期用生理盐水充气，以增加其尺寸并进一步扩大眼眶。眼眶组织扩张器的第一代原型已经制造完成；选定的聚合物在兔模型上进行了眼眶生物相容性测试，体外测试正在进行中。第一阶段的具体目标是1)使用标准的工程测量来表征材料和设备，2)优化设计、模具和生产手段，以重复提供设备，3)在体外测试设备的长期耐用性，以及4)开始在动物身上测试设备，以确定它是否真的可以被容忍并执行预期的功能。预计眼眶组织扩张器的第一阶段功能测试将证明机械和生物可行性。第二阶段将面向该设备的长期体内测试，加快轨道扩张器的生产，用于商业化、监管提交和临床测试。

DESCRIPTION (provided by applicant): This Small Business Innovation Research Phase I project is to develop and test an orbital tissue expander that can be used in the orbit (eye socket) of babies who are born either without an eye or with a small nonfunctioning eye. In both cases, the orbit must be physically expanded as the infant grows to prevent distortion of the face and permanent disfigurement. Current surgery to expand the orbit is very traumatic on the baby and requires removing the small eye, if present, and replacing it with a solid sphere. The solid sphere must then be replaced at least four times with larger spheres before the patient reaches puberty to ensure that the orbit grows symmetrically with the other eye. Besides being traumatic to the young patient, it is a costly surgical procedure that many patient families cannot afford. The SBIR project is to develop a simple inflatable sphere, called an orbital tissue expander, which will be secured in the eye socket and which serves to expand the orbit with time. The tissue expander is inflated (or deflated, if required) periodically with saline from a simple needle injection. This novel device will be significantly less traumatic to the patient as well as less expensive to perform sequential expansions versus the current surgical techniques. The device consists of an expanding "balloon" with an integral hydrogel seal that enables repeated puncture of the device without leakage. The device will be implanted into the eye orbit, secured in place with a bone plate and then periodically inflated with saline, to increase its size and further expand the orbit. First generation prototypes of the orbital tissue expander have been fabricated; the selected polymer tested for orbital biocompatibility in the rabbit model and in vitro testing is in progress. The specific aims of Phase I are 1) to characterize the material and device using standard engineering measurements, 2) to optimize the design, molds and production means to reproducibly provide the device, 3) to test the long-term durability of the device in vitro, and 4) to begin testing the device in animals to determine if it can indeed be tolerated and perform the function intended. It is anticipated that Phase I functional testing of the orbital tissue expander will demonstrate mechanical and biological viability. Phase II will be geared toward long-term in vivo testing of the device, stepping up production of the orbital expander for commercialization, regulatory submissions and clinical testing.