Electronic Stimulator of Lacrimal Gland

电子泪腺刺激器

• 批准号: 8477525
• 负责人: DANIEL V PALANKER
• 金额: $ 48.39万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8477525
• 关键词: Acute; Adhesives; Adverse effects; Affect; American; Animal Model; Animals; Blindness; Caring; Cells; Chemicals; Chronic; Clinical Research; Computer Simulation; Cornea; Development; Disease Progression; Dry Eye Syndromes; Electric Stimulation; Electrodes; Engineering; Excessive tearing; Eye; Eye diseases; FDA approved; Film; Frequencies; Gland; Glass; Health; Human; Implant; Infection; Inferior; Inflammation; Lacrimal gland structure; Nerve; Ocular orbit; Ophthalmologist; Oryctolagus cuniculus; Osmolar Concentration; Output; Patients; Pharmaceutical Preparations; Photophobia; Physicians; Physiologic pulse; Preparation; Production; Quality of life; Relative (related person); Risk; Safety; Shapes; Symptoms; Tea; Technology; Testing; Therapeutic; Therapeutic Effect; Time; Tissues; Translating; biomaterial compatibility; design; effective therapy; electric field; electronic stimulator; evaporation; eye dryness; improved; intense pain; ocular surface; public health relevance; response; transmission process

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.

描述（由申请人提供）：超过 2500 万美国人患有干眼症 (DED)，其中 300 万人患有最严重的干眼症 - 一种使人衰弱的疾病，且没有有效的治疗方法。 患者和医生都迫切需要治愈方法。 DED 的症状包括剧烈疼痛、光敏感、视力模糊、感染风险增加以及可能的粘蛋白缺失。 DED 眼表泪液量不足最初是由于泪液产生不足或泪液蒸发过多造成的。 泪液量不足会导致泪液渗透压过高，引起炎症和神经损伤，导致泪液产量和质量逐渐丧失。 RestasisTM - FDA 唯一批准的治疗 DED 的药物，仅使泪液产生增加 23%，因此不会显着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，通过电刺激泪腺可以显着增加泪液的产生。 我们假设泪液量的增加会改善泪膜渗透压、眼表健康、症状，从而改善生活质量。 它还可能逆转疾病的进展。 电流将通过插入眼眶泪腺附近的射频驱动微刺激器传送到泪腺。 刺激器安全、无痛地将电流输送到泪腺，恢复泪液产生。 电力通过放置在眼镜镜腿上的小型射频发射器或作为患者太阳穴上的粘合贴片以无线方式传输到刺激器。 对兔子泪腺的刺激表明，泪液产生量较基线显着增加：高达 7 倍（+600%）。 使用市售外部刺激器进行的急性临床研究显示，与基线相比，严重 DED 患者的泪液分泌量增加了 3 倍（+195%）。 与 RestasisTM 相比，这提高了 8 倍以上。 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并评估其功效和安全性。 我们将研究刺激机制，优化电极几何形状和波形，并评估动物模型中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好准备。