An Implantable Pacemaker Optimized for Smooth Muscle Stimulation

针对平滑肌刺激进行优化的植入式起搏器

• 批准号: 7599487
• 负责人: ROBERT Arthur ROSS
• 金额: $ 9.99万
• 依托单位: VIRGINIA TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-29 至 2009-09-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7599487
• 关键词: Animals; Devices; Disease; Electric Stimulation; Gastrointestinal Motility; Gastrointestinal tract structure; Gastroparesis; Goals; Knowledge; Muscle function; Obesity; Pacemakers; Phase; Physiologic pulse; Population; Public Health; Pulse taking; Quality of life; Rattus; Research; Safety; Series; Smooth Muscle; Techniques; Technology; United States Food and Drug Administration; clinical application; cost; design; gastrointestinal; in vivo; motility disorder; prototype; response

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.

描述（由申请人提供）：使用器械电刺激平滑肌证明在与胃肠道相关的临床应用中特别有用。具体而言，电刺激已被证明在治疗胃轻瘫和肥胖症等适应症方面是有效的。然而，围绕平滑肌刺激器装置的技术尚未优化。这可以主要归因于围绕平滑肌对各种电参数刺激的响应的知识和研究的差距。该项目的长期目标是设计、构建和商业化一种完全植入式、FDA批准的平滑肌电刺激装置，该装置采用节能技术。阶段I的具体目的是通过实验确定用于能量有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。为了实现该目标，将进行大鼠体内研究，以使用矩形和指数波形确定不同持续时间下收缩的电刺激电流阈值。最小能量参数然后可以从该信息导出。公共卫生关系：功能性胃肠道和动力障碍导致高达25%的美国人口生活质量下降，仅在美国每年的成本就高达300亿美元（34）。所提出的节能胃肠电刺激设备的可用性将有助于提高与胃肠动力障碍相关的生活质量。