An Implantable Pacemaker Optimized for Smooth Muscle Stimulation

描述（由申请人提供）：便秘是一种常见症状，影响西方国家2%至27%的人口。在美国，每年有超过250万人次就诊，92，000人住院，泻药销售额高达数亿美元。使用电刺激平滑肌的装置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包括胃轻瘫和肥胖症以及最近的慢性便秘的适应症中是有效的。围绕平滑肌刺激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。我们的第一阶段项目的具体目标是通过实验确定最佳电脉冲波形类型和脉冲持续时间，用于能量有效刺激平滑肌。总之，结果显示，与使用传统矩形恒定电流脉冲相比，当使用具有预先测量的电荷转移的截断指数双相波形时，平均节能44%。本II期提案的目的是设计、构建和测试一种用于治疗慢性便秘的节能型植入式平滑肌刺激装置。该设备将提供最佳的电脉冲参数和脉冲形状，以实现第一阶段研究中确定的最大能效。然后将在犬受试者中进行一系列结肠运输研究，以证明该器械的安全性和有效性。这项研究的长期目标是设计，建造和商业化一个完全植入式的，FDA批准的，节能的平滑肌电刺激设备，以治疗慢性便秘。 公共卫生相关性：慢性便秘导致高达27%的美国人口生活质量下降，每年有250万人就医和92，000人住院。大多数药物治疗（即，泻药）对治疗慢性便秘无效。拟议的节能结肠动力起搏器（CMP-1）的可用性将有助于提高与慢性便秘相关的生活质量。

DESCRIPTION (provided by applicant): Constipation is a common symptom affecting between 2 percent and 27 percent of the population in Western countries. In the United States, it results in more than 2.5 million visits to physicians, 92,000 hospitalizations, and laxative sales of several hundred million dollars a year. 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 including gastroparesis and obesity and more recently, chronic constipation. The technology surrounding smooth muscle stimulation 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 specific aim of our Phase I project was to experimentally determine the optimal electrical pulse waveform type and pulse duration for the energy efficient stimulation of smooth muscle. In summary, the results show an average energy savings of 44% when using truncated exponential biphasic waveforms with pre- measured charge transfer as compared to using traditional rectangular constant current pulses. The objective of this phase II proposal is to design, build, and test an energy efficient implantable smooth muscle stimulation device for the treatment of chronic constipation. The device will deliver the optimal electrical pulse parameters and pulse shape for maximum energy efficiency as determined in the Phase I research. A series of colonic transit studies will then be performed in canine subjects to demonstrate the safety and efficacy of the device. The long-term goal of this research is to design, build, and commercialize a fully implantable, FDA approved, energy efficient smooth muscle electrical stimulation device to treat chronic constipation. PUBLIC HEALTH RELEVANCE: Chronic constipation causes a decreased quality of life in up to 27% of the U.S. population, and is associated with 2.5 million visits to doctors and 92,000 hospitalizations annually. Most pharmaceutical treatments (i.e., laxatives) are not effective in treating chronic constipation. Availability of the proposed energy efficient Colon Motility Pacer (CMP-1) will help to increase the quality of life associated with chronic constipation.