An Implantable Pacemaker Optimized for Smooth Muscle Stimulation

描述（由申请人提供）：使用电刺激平滑肌的装置被证明在与胃肠道相关的临床应用中特别有用。具体来说，电刺激已被证明对胃轻瘫和肥胖等适应症的治疗有效。然而，围绕平滑肌刺激装置的技术尚未得到优化。这主要归因于围绕平滑肌对各种电参数刺激的反应的知识和研究的空白。该项目的长期目标是设计、制造并商业化一种完全可植入的、经FDA批准的平滑肌电刺激装置，该装置结合了节能技术。第一阶段的具体目的是通过实验确定能量高效刺激平滑肌的最佳电脉冲波形类型和脉冲持续时间。在第二阶段，这些参数将被纳入商业原型。为了实现这一目标，将对大鼠进行体内研究，以确定在不同持续时间下电刺激电流的收缩阈值，使用矩形和指数波形。然后就可以从这些信息中得到最小能量参数。公共卫生相关性：功能性胃肠道和运动障碍导致高达25%的美国人口生活质量下降，仅在美国每年就造成高达300亿美元的相关费用（34）。所提出的节能胃肠道电刺激装置的可用性将有助于提高与胃肠道运动障碍相关的生活质量。

DESCRIPTION (provided by applicant): The use of a device to electrically stimulate smooth muscle proves particularly useful in clinical applications associated with the gastrointestinal tract. Specifically, electrical stimulation has been shown to be effective in the treatment of indications like gastroparesis and obesity. However, the technology surrounding smooth muscle stimulator devices has not been optimized. This can primarily be attributed to a gap in knowledge and research surrounding the response of smooth muscle to stimulation with various electrical parameters. The long-term objective of this project is to design, build, and commercialize a fully implantable, FDA approved, smooth muscle electrical stimulation device, which incorporates energy saving techniques. The specific aim of Phase I is to experimentally determine the optimal electrical pulse waveform type and pulse duration for the energy efficient stimulation of smooth muscle. In Phase II, these parameters will be incorporated into a commercial prototype. To accomplish the aim, an in vivo rat study will be performed to determine the electrical stimulation current thresholds for contraction at various durations, using rectangular and exponential waveforms. The minimal energy parameters can then be derived from this information. PUBLIC HEALTH RELEVANCE: Functional gastrointestinal and motility disorders cause a decreased quality of life in up to 25% of the U.S. population, and are associated with costs of up to $30 billion annually in the U.S. alone (34). Availability of the proposed energy efficient gastrointestinal electrical stimulation device will help to increase the quality of life associated with gastrointestinal motility disorders.