A Novel RF TENS Device for Acute Pain Management

描述(申请人提供)：Cyclotec AMT，Inc.正在开发“非侵入性”经皮电刺激器(TENS)，这种刺激器可能被证明是治疗新近发作的“急性”疼痛的药物的可行附件或替代品。TENS长期以来一直被用于“慢性”疼痛治疗。设备的复杂性使它们无法应用于短期的“尖锐”应用；这项技术有望很好地适用于这种应用。Cyclotec针对急性适应症的“新颖”开发包括：小型化、无线操作、远程控制激活、多种脉冲功能、耐用性、操作简单化、延长电池寿命，以及几乎可以放置在身体的任何位置。远程控制(RF)功能使患者可以轻松控制目前正在开发的刺激设备--而不需要在所有其他TEN单元上安装必要的延长线--无论这些单元放置在身体的什么位置，例如背部、颈部、肩部、髋部等。在完成12个功能原型单元的开发后，将在不同的临床地点进行初步的试点研究，以确定在联合药物治疗和没有药物治疗的情况下的疗效，以确定急性疼痛的治疗效果。如果TENS被证明像该公司希望的那样有效、简单和舒适，那么Cyclotec AMT设备将找到一个重要的利基市场，因为TENS几乎没有警告或警告，而众所周知，药物具有长期的中度至严重副作用。

DESCRIPTION (provided by applicant): Cyclotec AMT, Inc. is developing 'non-invasive' transcutaneous electrical stimulators (TENS) that may prove to be viable adjuncts to or alternatives for drugs for management of recent onset "acute" pain. TENS has long been used for "chronic" pain management. The device complexities have made them prohibitive for short-term 'acute' applications; an application for which the technology promises to be well suited for. Cyclotec's 'novel' developments for acute indications include: miniaturization, wireless operation, remote control activation, multiple pulsing features, durability, simplification of operation, extended battery life, and the capability of placement virtually anywhere on the body. The remote control (RF) features allow the stimulation devices now in development to be easily controlled by the patient - without the extension wires necessary on all other TENS units - no matter where the units are placed on the body, e.g., back, neck, shoulder, hip, and etc. Upon completion of development of 12 functional prototype units, initial pilot investigations at various clinical sites will be performed to establish efficacy in conjunction with medication and with the absence of medication in a double-blinded study to determine effectiveness in treatment of acute pain. Should TENS prove as effective, simple and comfortable to wear by patients as the company hopes they will be, Cyclotec AMT devices will find a significant market niche as TENS has few cautions or warnings while drugs are well known to have long-term moderate to severe side effects.