Epoch Telemetry System for Long-Term Monitoring of Biopotentials

描述（由申请人提供）：用于长期监测生物电位的Epoch遥测系统摘要Epoch”是一种无线、多通道生物电位记录系统，设计用于在I期和II期开发的人类疾病的小动物转化研究模型。从疾病的动物模型获得长期连续记录是转化研究的关键组成部分，该转化研究旨在开发用于衰弱性疾病（如癫痫、心脏病、脑肿瘤、创伤性脑损伤和肥胖症）的新疗法。最近开发了许多未成熟和成年啮齿动物模型，这些模型是人类Epitel Epoch无线6通道生物电位记录系统在儿科和成人人群中表现为进行性疾病的替代品。在系留时（即，“有线”）的生物电势记录可以周期性地获得（即，在未成熟的啮齿动物中，每次几分钟到几个小时），这些记录具有与大鼠和小鼠的小尺寸相关的问题。记录可以获得数周或数月的时间从成年大鼠与栓系或遥测记录系统;然而，这两种系统都有局限性。动物越年轻或越小，获得足够的记录就越困难，并且几乎不可能获得长时间的连续记录-特别是在小鼠中。无线、多模式、多通道解决方案，用于长时间记录生物电位 在小鼠中尚未在市场上提供。Epitel将通过广泛扩展Epoch系统的单模态电生理功能以包括多模态换能器来满足IIb期的这一需求。该项目有3个主要目标：1）开发用于心脏应用的无线血压和压力-容积传感器，2）为我们的客户提供立体定向精确植入多个电极靶向脑深部结构的能力，以及3）在一个笼子里同时记录多达四只动物。Epoch是唯一一个能够在成年啮齿动物和体重仅为6克的新生动物中进行多达6个通道的生物电位记录的无线系统。Epoch记录系统的基本原理是电容耦合技术.遥测单元的小尺寸（<1 g）和低轮廓（<1 cc）将允许多个 同时记录大鼠或小鼠的脑皮层和脑深部电生理、温度、血压和直接来自左心室的压力-容积、颅内压、心电图、肌电图和视频记录，不间断长达6个月。长期目标是让研究人员能够在转化研究中使用Epoch系统，为进行性人类疾病的动物模型开发新的疗法。Epoch是唯一能够记录成年大鼠和小鼠以及新生动物（P6大鼠; P8小鼠）从断奶到成年的生物电位的系统，以提供疾病进展性质的完整报告，这对于将潜在治疗转化为临床非常重要。Epoch发射器的简单性使得开发复杂的、完全仪器化的人类疾病小动物模型变得更加容易。

DESCRIPTION (provided by applicant): Epoch Telemetry System for Long-Term Monitoring of Biopotentials ABSTRACT Epoch" is a wireless, multi- channel biopotential recording system designed for small animal translational research models of human disease developed in Phase I and II. Obtaining long- term continuous recordings from animal models of disease is a critical component of translational research aimed at developing new therapies for debilitating disorders, such as epilepsy, heart disease, brain tumor, traumatic brain injury, and obesity. Many immature- and adult-rodent models have recently been developed that are surrogates for human Epitel Epoch Wireless 6 Channel Biopotential Recording System manifestations of progressive disease in the pediatric and adult populations. While tethered (i.e., "wired") recordings of biopotentials can be obtained periodically (i.e., for minutes to a few hours per session in immature rodents), these recordings have problems associated with the small size of rats and mice. Recordings can be obtained for weeks or months at a time from adult rats with either tethered or telemetric recording systems; however, both of these systems have limitations. The younger or smaller the animal, the more difficult it is to obtain adequate recordings, and it is nearly impossible to obtain prolonged, continuous recordings - especially in mice. A wireless, multi- modal, multi-channel solution for recording biopotentials for long periods in mice has not yet been made available in the marketplace. Epitel will address this need in Phase IIb by broadly expanding the unimodal electrophysiology capabilities of the Epoch system to include multimodal transducers. The project has 3 main goals: 1) to develop wireless blood pressure and pressure-volume transducers for cardiac applications, 2) to provide our customers the ability to implant multiple electrodes targeting deep brain structures with stereotactic precision, and 3) to enable simultaneous recording from up to four animals in a single cage. Epoch is the only wireless system able to make up to 6 channels of biopotential recordings in not only adult rodents, but also neonatal animals that weigh as little as 6 grams. The fundamental principle of the Epoch recording system is that the capacitive- coupled technology. The small size (<1 g) and low profile (<1 cc) of the telemetry unit will allow multiple rats or mice to be recorded simultaneously, enabling continuous cortical and deep brain electrophysiology, temperature, blood pressure and pressure-volume directly from the left ventricle, intracranial pressure, electrocardiogram, electromyogram, and video recordings uninterrupted for up to 6 months. The long-term goal is for researchers to be able to use the Epoch system in translational research to develop new therapies for animal models of progressive human disease. Epoch is the only system capable of recording biopotentials from adult rats and mice and neonatal animals (P6 rat; P8 mouse) continuously through weaning into adulthood to provide a full report of the progressive nature of disease, which is important for translation of a potential therapy to the clinic. The simplicity of the Epoch transmitter makes it easier to develop sophisticated, fully instrumented small animal models of human disease.