Electronic Stimulator of Lacrimal Gland

电子泪腺刺激器

基本信息

批准号：
8827350
负责人：
DANIEL V PALANKER
金额：
$ 46.63万
依托单位：
STANFORD UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-04-01 至 2017-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8827350
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 Geometry 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 response transmission process

项目摘要

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2500万的美国人患有干眼病（DED），有300万人患有最严重的形式 - 一种使人衰弱的状况，没有有效的治疗。患者和医生迫切需要治愈。 DED的症状包括剧烈的疼痛，光敏性，模糊，感染风险增加以及可能的visin丧失。 DED中眼表面的撕裂体积不足最初是由于TER产生或过度泪液蒸发引起的。泪液量不足会导致泪液高渗透性，导致炎症和神经损伤，导致造成泪液产生和质量的逐渐丧失。 RESTASISTM-唯一获得FDA治疗DED的药物，仅将撕裂的产量增加23％，因此不会显着减慢或反向疾病的进展。我们在人类和动物模型中都证明了泪腺的电刺激可以大大增加泪液的产生。我们假设增加的泪液量应改善泪膜渗透率，眼表面健康，症状以及因此生活质量。它也可能扭转疾病的进展。电流将通过插入泪腺旁边的眼轨道的RF驱动的微型刺激器传递到泪腺。刺激器安全且无痛地将电流传递到泪腺，从而恢复撕裂产生。电源是通过放置在玻璃神庙上的小型RF发射器或患者庙上的粘合剂贴片中无线传输到刺激器的。在兔子中刺激泪腺的刺激表明，基线的泪产生急剧增加：最高7倍（+600％）。与基线相比，具有市售外部刺激剂的急性临床研究导致严重DED患者的泪产生3倍（+195％）。与RestAsistm相比，这改善了8倍以上。该项目汇集了工程师和眼科医生的独特组合，以完成开发并评估泪腺刺激剂的功效和安全性。我们将研究刺激，优化电极几何形状和波形的机制，并评估动物模型中慢性刺激的生物相容性，安全性和功效，以准备将该技术转化为临床研究。