Development of an Orbital Tissue Expander for Babies

婴儿眼眶组织扩张器的开发

• 批准号: 6690938
• 负责人: Leonard Pinchuk
• 金额: $ 10.75万
• 依托单位: INNOVIA, LLC
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-01 至 2004-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6690938
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; cats; congenital eye disorder; developmental disease /disorder; infant human (0-1 year); tensile strength; tissues

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.

描述（由申请人提供）：该小型企业创新研究第一阶段项目旨在开发和测试一种眼眶组织扩张器，可用于出生时无眼或小无功能婴儿的眼眶（眼窝）。在这两种情况下，随着婴儿的成长，眼眶必须在物理上扩大，以防止面部变形和永久性毁容。目前扩大眼眶的手术对婴儿来说是非常痛苦的，需要切除小眼睛（如果有的话），并用实心球体替换它。在患者进入青春期之前，必须用较大的球体更换至少四次实心球体，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，这是一种昂贵的手术，许多患者家庭无法承担。 SBIR 项目旨在开发一种简单的充气球体，称为眼眶组织扩张器，将其固定在眼窝中，并随着时间的推移扩大眼眶。通过简单的针注射，定期用盐水对组织扩张器进行充气（或放气，如果需要）。与目前的手术技术相比，这种新颖的装置对患者的创伤明显较小，并且执行顺序扩张的成本也较低。 该装置由一个膨胀的“气球”和一个整体水凝胶密封件组成，可以重复刺穿该装置而不会泄漏。该装置将被植入眼眶，用骨板固定到位，然后定期用盐水充气，以增加其尺寸并进一步扩大眼眶。第一代眼眶组织扩张器原型已经制造出来；所选聚合物在兔子模型中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) 使用标准工程测量来表征材料和设备，2) 优化设计、模具和生产方式以可重复地提供设备，3) 在体外测试设备的长期耐用性，4) 开始在动物身上测试设备，以确定它是否确实可以耐受并执行预期功能。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。第二阶段将致力于该设备的长期体内测试，加快轨道扩张器的生产，以实现商业化、监管提交和临床测试。

项目成果

Evaluation of an integrated orbital tissue expander in an anophthalmic feline model.

在无眼猫科动物模型中评估集成眼眶组织扩张器。

• DOI: 10.1016/j.ajo.2006.10.028
• 发表时间: 2007
• 期刊: American journal of ophthalmology
• 影响因子: 4.2
• 作者: Tse,DavidT;Pinchuk,Leonard;Davis,Stewart;Falcone,StevenF;Lee,Wendy;Acosta,AnaCaroline;Hernandez,Eleut;Lee,Elizabete;Parel,Jean-Marie
• 通讯作者: Parel,Jean-Marie

Evaluation of an integrated orbital tissue expander in congenital anophthalmos: report of preliminary clinical experience.

先天性无眼症综合眼眶组织扩张器的评估：初步临床经验报告。

• DOI: 10.1016/j.ajo.2010.09.009
• 发表时间: 2011
• 期刊: American journal of ophthalmology
• 影响因子: 4.2
• 作者: Tse,DavidT;Abdulhafez,Mohammad;Orozco,MarciaA;Tse,JeffreyD;Azab,AmrOsama;Pinchuk,Leonard
• 通讯作者: Pinchuk,Leonard