Endoscopy-assisted intracochlear access via ultrasharp-microneedles

通过超锋利微针进行内窥镜辅助耳蜗内通路

• 批准号: 10699330
• 负责人: Aykut Aksit
• 金额: $ 35万
• 依托单位: HAYSTACK MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10699330
• 关键词: 3D Print; Age; Anatomy; Audiology; Cadaver; Cavia; Clinical Trials; Cochlea; Confocal Microscopy; Data; Development; Devices; Diagnosis; Diagnostic; Diameter; Dimensions; Drug Delivery Systems; Ear; Endoscopes; Endoscopy; Ensure; Exclusion; External auditory canal; Goals; Grant; Hearing problem; Hospitals; Human; Injections; Intellectual Property; Interdisciplinary Study; Knowledge; Labyrinth; Legal patent; Liquid substance; Marketing; Measures; Medical; Medical Device; Medicine; Membrane; Methods; Modeling; Needles; Noise; Outcome; Patients; Perforation; Perilymph; Persons; Pharmaceutical Preparations; Phase; Positioning Attribute; Procedures; Running; Sampling; Secure; Small Business Technology Transfer Research; Source; Symptoms; Technology; Temporal bone structure; Testing; Thumb structure; Time; Translations; Trauma; Tube; Tympanic membrane; Universities; Visual; Work; World Health Organization; aspirate; commercial application; commercialization; design; empowerment; equilibration disorder; healing; hearing impairment; inner ear diseases; insight; invention; journal article; middle ear; minimally invasive; novel; personalized diagnostics; public health relevance; round window; safety study; stem; success; technological innovation; tool

PROJECT SUMMARY / ABSTRACT Up to 2.5 billion people worldwide will suffer from hearing loss or balance disorders by 2050, with a significant portion having underlying causes in the inner ear. This includes hearing loss due to age, noise and medications as well as various balance disorders, which in total afflicts approximately one in three people between the ages of 65 and 751. Atraumatic medical access into the inner ear is presently not possible, making diagnosis and treatment of cochlear-based hearing and balance disorders imprecise, relying on exclusion of other potential causes. Haystack Medical, Inc. is developing technology to provide clinicians with safe, direct access into the inner ear for diagnostic purposes. The product is called Endoscopy-Assisted intRacochlear aCcess via Ultrasharp-micRonEedles (EarCure). The founding team has been working together on this problem as an interdisciplinary research group out of Columbia University for the past decade. In this time, they have authored 12 journal articles and applied for 11 patents, 2 of which have been granted and 9 are pending. The team has invented and developed precision microneedle technology and carried out safety studies where they reach the inner ear through the delicate round window membrane. They are now turning this tool into a device that provides routine, safe access to the inner ear for valuable diagnostic data. Haystack Medical envisions this product to become a routine tool that will be used to diagnose the underlying cause of hearing loss and balance disorders, and help craft the best course or precise treatment for patients. For this purpose, in this STTR Phase I project, EarCure will be used to access the inner ear of human cadaveric temporal bones, only going through the tympanic membrane, making a hole as small as an ear tube for rapid healing. Furthermore, EarCure will be used to draw 1 µL amount of fluid from inside the inner ear, enough for diagnostic purposes, therefore demonstrating feasibility of the device. In the planned Phase II of the project, the team expects to enter clinical trials and begin translation of the tool to reach patients. The potential market for EarCure consists of all patients suffering from hearing and/or balance disorders with root causes in the inner ear. In the US alone, the market size for diagnosing hearing and balance disorders is greater than $5B, due to the number of people who seek treatment because of inner ear symptoms. Haystack intends the device to be sold through hospitals and reimbursed as other disposable medical devices. The company expects to pursue 510(k) clearance of the microneedle and actuation device, and will pursue a PMA if the FDA considers this device to be significantly different from predicates.

项目摘要/摘要 到2050年，全球将有多达25亿人遭受听力损失或平衡障碍的痛苦， 在内耳有潜在原因的部分。这包括因年龄、噪音和药物造成的听力损失。 以及各种平衡障碍，这些疾病总共困扰着大约三分之一的人 65号和751号。目前，非创伤性医疗进入内耳是不可能的，做出诊断和 依靠排除其他潜能治疗不精确的人工耳蜗性听力和平衡障碍 原因。 Hystack Medical，Inc.正在开发技术，为临床医生提供安全、直接进入 用于诊断的内耳。该产品被称为内窥镜辅助INTACCHLEAR Access Via 超锐-微针(EarCure)。创始团队一直在为解决这个问题而共同努力 在过去的十年里，哥伦比亚大学成立了跨学科研究小组。在这段时间里，他们有 发表期刊论文12篇，申请专利11项，其中2项已获授权，9项正在申请中。这个 团队发明和开发了精密微针技术，并进行了安全性研究， 通过精致的圆形窗膜到达内耳。他们现在正在把这个工具变成一种装置 这为有价值的诊断数据提供了常规的、安全的内耳通道。 Heystack Medical预计这款产品将成为诊断疾病的常规工具 听力损失和平衡障碍的潜在原因，并帮助制定最佳疗程或精确治疗 病人。为此，在STTR第一阶段项目中，EarCure将被用来访问人类的内耳 身体的颞骨，只穿过鼓膜，形成一个耳管大小的洞 以求快速康复。此外，还将使用EarCure从内耳内抽取1微克L液体， 足够用于诊断目的，因此证明了该设备的可行性。 在该项目计划的第二阶段，该团队预计将进入临床试验并开始翻译 帮助患者的工具。EarCure的潜在市场包括所有听力障碍患者 和/或内耳有根本原因的平衡障碍。 仅在美国，诊断听力和平衡障碍的市场规模就超过50亿美元 因为内耳症状而寻求治疗的人数。干草堆打算让这个设备 通过医院出售，并作为其他一次性医疗器械报销。该公司预计将 追求微针和驱动装置的510(K)许可，如果FDA考虑，将寻求PMA 这一手段与谓词有很大不同。