Electronic Stimulator of Lacrimal Gland

描述（由申请人提供）：超过2500万美国人患有干眼病（DED），其中300万人患有最严重的形式-一种没有有效治疗的衰弱状态。病人和医生都迫切希望找到治疗方法。DED的症状包括剧烈疼痛、对光敏感、视力模糊、感染风险增加以及可能的视力丧失。DED患者眼表泪液量不足最初是由于泪液分泌不足或泪液蒸发过度引起的。泪液体积不足导致泪液高渗，引起炎症和神经损伤，导致泪液产生和质量的逐渐丧失。RestasisTM是FDA批准的唯一治疗DED的药物，仅能增加23%的眼泪产生，因此不能显著减缓或逆转疾病的进展。我们已经在人类和动物模型中证明，泪腺的电刺激可以显著增加泪液的产生。我们假设泪液体积的增加可以改善泪膜渗透压、眼表健康、症状和生活质量。它还可能逆转疾病的发展。电流将通过插入泪腺旁边的眼眶的射频微刺激器传递到泪腺。刺激器安全无痛地向泪腺输送电流，恢复泪液分泌。能量通过放置在眼镜太阳穴上的小型射频发射器无线传输到刺激器，或者作为患者太阳穴上的粘合剂。兔的泪腺刺激显示泪液产生比基线显著增加：高达7倍（+600%）。与基线相比，使用市售外部刺激器的急性临床研究导致严重DED患者泪液产量增加3倍（+195%）。与RestasisTM相比，这是8倍以上的改进。该项目汇集了工程师和眼科医生的独特组合，以完成泪腺刺激器的开发和评估有效性和安全性。我们将研究刺激机制，优化电极几何形状和波形，并在动物模型中评估慢性刺激的生物相容性、安全性和有效性，为将该技术转化为临床研究做准备。

DESCRIPTION (provided by applicant): More than 25 million Americans have Dry Eye Disease (DED) with 3 million suffering from the most severe form - a debilitating condition with no effective treatments. Patients and physicians are desperate for a cure. Symptoms of DED include intense pain, light sensitivity, blurriness, increased risk of infection, and possible visin loss. Insufficient tear volume on the ocular surface in DED is initially caused by insufficient ter production or excessive tear evaporation. Insufficient tear volume results in tear hyperosmolarity, causing inflammation and nerve damage, leading to progressive loss of tear production and quality. RestasisTM - the only FDA approved medication for the treatment of DED, increases tear production by only 23%, and therefore does not significantly slow or reverse progression of the disease. We have demonstrated in both humans and in animal model that tear production can be dramatically increased by electrical stimulation of the lacrimal gland. We hypothesize that increase in tear volume should improve tear film osmolarity, ocular surface health, symptoms and therefore quality of life. It may also reverse the progression of disease. Electric current will be delivered to lacrimal gland via a RF- powered micro-stimulator inserted into the eye orbit next to the lacrimal gland. The stimulator safely and painlessly delivers electrical current to the lacrimal gland, restoring tear production. Power is wirelessly transmitted to the stimulator from a small RF transmitter placed on the temple of glasses, or as an adhesive patch on the patient's temple. Stimulation of lacrimal gland in rabbits demonstrated a dramatic increase in tear production over baseline: up to 7-fold (+600%). Acute clinical study with a commercially available external stimulator resulted in 3-fold (+195%) increase in tear production in patients with severe DED, compared to baseline. This is more than 8-fold improvement compared to RestasisTM. This project brings together a unique combination of engineers and ophthalmologists to complete the development and evaluate the efficacy and safety of the lacrimal gland stimulator. We will study the mechanisms of stimulation, optimize the electrode geometry and waveforms, and assess biocompatibility, safety and efficacy of chronic stimulation in animal model in preparation for translating this technology to clinical studies.