hANDY-i(TM): A non-invasive, dual-sensor handheld imager for intraoperative preservation of parathyroid glands

摘要 术后甲状旁腺功能减退或低钙血症是众所周知的经常发生在甲状腺手术后 由于错误识别和/或意外切除健康的甲状旁腺。约 在美国进行了150，000例甲状腺切除术，其中27%的患者患有一过性或 永久性低钙血症，可导致终身后遗症和社会经济负担。因为 小尺寸、可变位置和与周围组织相似的外观， 淋巴结，脂肪和甲状腺，低容量外科医生往往很难区分甲状旁腺 甲状腺组织的腺体。此外，甲状旁腺的血液供应是脆弱的， 在剥离过程中容易损坏。这是一个具有挑战性的问题，因为临床上很难通过 目视检查腺体在操作后是否仍有活力。目前还没有标准化或 实用设备可用于定位和评估可行性的甲状旁腺在真实的时间和在一个 手术过程中无创。因此，任何可行的解决办法都将被视为重要的， 内分泌系统 在这项研究中，我们建议开发一种非侵入性的手持式成像仪， 为甲状腺肿瘤患者提供了一个改变范例的工具。我们的成像解决方案称为hANDY-iTM， 允许1）非侵入性甲状旁腺识别和2）组织活力的无缝显示， 在甲状腺手术中实时保存甲状旁腺。这项研究将是一个 结合Optosurgical，LLC和约翰霍普金斯的技术和临床专业知识的共同努力 医院为了验证我们的假设，我们将研究以下具体目标：目标1：临床可行 原型开发;目标2：临床试验，以确认所提出的系统（N=64）;目标3： 上市前器械评价。 我们设想，我们的技术将为无染料， 时间不受限制，精确的甲状旁腺检测和保存。成功的翻译 技术将潜在地降低甲状腺手术中甲状旁腺功能减退的风险， 临床结果。

Abstract Post-surgical hypoparathyroidism or hypocalcemia are known to occur frequently after thyroid surgeries due to the misidentification and/or accidental removal of healthy parathyroid glands. Approximately 150,000 thyroidectomies are performed in the US, 27% of these patients suffer from transient or permanent hypocalcemia, which can lead to lifelong sequelae and socioeconomic burden. Because of the small size, the variable position, and the similar appearance to the surrounding tissues such as lymph node, fat, and thyroid gland, it is often difficult for low volume surgeons to distinguish parathyroid glands from thyroid tissue. Furthermore, blood supply to parathyroid glands is fragile and can be damaged easily during dissection. This is a challenging problem because it is clinically hard to tell by visual inspection if a gland is still viable after manipulation. There are currently no standardized or practical equipment available to localize and assess viability of parathyroid glands in real time and in a non-invasive manner during operation. Thus, any viable solution would be considered as significant to the endocrine community. In this research, we propose to develop a non-invasive, handheld imager that will potentially be a paradigm changing tool for patients with thyroid tumors. Our imaging solution, called hANDY-iTM, will permit 1) a non-invasive parathyroid gland identification and 2) seamless display of tissue viability in real-time for the preservation of the parathyroid glands during thyroid surgery. This research will be a joint effort combining the technical and clinical expertise of Optosurgical, LLC and Johns Hopkins Hospital. To validate our hypothesis, we will study the following specific aims; Aim1: Clinically viable prototype development; Aim 2: Clinical trials to validate the proposed system (N=64); Aim3: Premarket device evaluation. We envision that our technology will open a new door for the digital imaging paradigm of dye-free, temporally unlimited, and precise parathyroid detection and preservation. Successful translation of this technology will potentially reduce the risk of hypoparathyroidism during thyroid surgery and improve the clinical outcomes.