A Multi-Channel Gastric Pacer for Treating Gastroparesis

治疗胃轻瘫的多通道胃起搏器

• 批准号: 6693878
• 负责人: ROBERT Arthur ROSS
• 金额: $ 30.52万
• 依托单位: VIRGINIA TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-15 至 2005-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6693878
• 关键词: biological models; biomaterial compatibility; biomaterial development /preparation; biotechnology; computer program /software; computer system design /evaluation; dogs; energy source; gastrointestinal stimulator; medical implant science; nonhuman therapy evaluation; paralysis; stomach; stomach emptying; stomach motility /pressure; stomach surgery

DESCRIPTION (provided by applicant): In a new therapeutic approach for delayed gastric emptying and gastroparesis, Virginia Technologies, Inc. (VTI) proposes: (1) to develop a 4-channel implantable gastric pacemaker, using pulse train electrical signals and capacitive coupling for patient safety and energy efficiency; (2) to develop a multi-channel pacing lead, optimized for gastric applications; (3) to develop a transcutaneous programmer and wand, enabling healthcare providers to customize and optimize pacing parameters to the needs of each patient; and (4) to test this system in animal models, studying safety and efficacy. The long-term goal of this research is to develop an implantable device for the superior treatment of motility disorders associated with gastroparesis in humans. Electrical stimulation of the gastrointestinal organs represents a promising new treatment for gastric motility disorders. These organs have natural pacemakers that generate myoelectrical activity, regulating contractions and motility. Myoelectrical abnormalities can disturb muscular activity, impairing contraction and leading to delay or failure of gastric emptying. In gastroparesis, impaired gastric emptying can lead to nausea, vomiting, premature satiety, abdominal pain, abdominal bloating, weight loss, bacterial overgrowth, and obstruction, as well as difficulties in managing blood glucose levels in diabetics. Traditional therapies for gastroparesis including, prokinetic medications, tube feeding via jejunostomy and total parenteral nutrition (TPN), have various limitations. A number of patients are refractory to the available medications, which also pose the risk of side effects and medicinal interactions. Jejunostomy and TPN offer nutritional support and address the symptoms of gastroparesis, but pose quality-of-life issues and do not correct the underlying disorder. Single-point, low-energy electrical stimulation, such as that provided by Medtronic's Enterra TM Therapy, also generally treats symptoms of nausea and vomiting, rather than the underlying disorder. In a new treatment option for motility disorders, the multi-channel phased gastric pacemaker uses electrical pacing to mimic the natural propagation of gastric slow waves. It generates peristaltic electrical waves that progress from the proximal to the distal stomach, seeking to entrain gastric slow waves, normalize gastric myoelectrical dysrhythmias, and normalize gastric emptying. Recent studies have shown that multi-channel pacing entrains gastric slow waves more effectively than prior single-channel high-energy approaches, and that a multi-channel design requires less energy, making it more appropriate for a long-term human-implantable therapeutic device.

描述（由申请人提供）：在胃排空延迟和胃轻瘫的新治疗方法中，Virginia Technologies，Inc. (VTI)建议：（1）开发一种4通道植入式胃起搏器，使用脉冲序列电信号和电容耦合，以确保患者安全和能效;（2）开发一种多通道起搏导线，针对胃应用进行优化;（3）开发经皮程控仪和程控棒，使医疗保健提供者能够根据每位患者的需求定制和优化起搏参数;（4）在动物模型中测试该系统，研究安全性和有效性。本研究的长期目标是开发一种可植入装置，用于对人类胃轻瘫相关动力障碍进行上级治疗。电刺激胃肠道器官代表了一种有前途的新的治疗胃动力障碍。这些器官有天然的起搏器，产生肌电活动，调节收缩和运动。肌电异常可干扰肌肉活动，损害收缩并导致胃排空延迟或失败。在胃轻瘫中，胃排空受损可导致恶心、呕吐、过早饱腹感、腹痛、腹胀、体重减轻、细菌过度生长和梗阻，以及难以控制糖尿病患者的血糖水平。胃轻瘫的传统疗法包括促动力药物、经空肠造口的管饲和全胃肠外营养（TPN），具有各种局限性。许多患者对现有药物难以耐受，这也带来了副作用和药物相互作用的风险。空肠造口术和TPN提供营养支持，并解决胃轻瘫的症状，但造成生活质量问题，并没有纠正潜在的疾病。单点、低能量电刺激，如Medtronic的Enterra TM疗法，通常也治疗恶心和呕吐症状，而不是潜在的疾病。在运动障碍的一种新的治疗选择中，多通道相控胃起搏器使用电起搏来模拟胃慢波的自然传播。它产生蠕动电波，从近端到远端的胃，试图夹带胃慢波，正常化胃肌电节律障碍，并正常化胃排空。最近的研究表明，多通道起搏比先前的单通道高能量方法更有效地携带胃慢波，并且多通道设计需要更少的能量，使其更适合于长期人体植入式治疗器械。