A Multi-Channel Gastric Pacer for Treating Gastroparesis

描述(由申请人提供)：在一种治疗胃排空延迟和胃瘫的新方法中，弗吉尼亚技术公司(VTI)提议：(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，以确保患者的安全和能量效率；(2)开发一种针对胃应用进行优化的多通道起搏导线；(3)开发经皮编程器和棒，使医疗保健提供者能够根据每个患者的需求定制和优化起搏参数；以及(4)在动物模型中测试该系统，研究安全性和有效性。这项研究的长期目标是开发一种植入式设备，用于更好地治疗与胃瘫相关的人类运动障碍。电刺激胃肠器官是治疗胃动力障碍的一种很有前途的新方法。这些器官有天然的起搏器，可以产生肌电活动，调节收缩和运动。肌电异常可扰乱肌肉活动，损害收缩，导致胃排空延迟或失败。在胃瘫患者中，胃排空障碍会导致恶心、呕吐、早饱、腹痛、腹胀、体重减轻、细菌过度生长和梗阻，以及糖尿病患者控制血糖水平的困难。胃轻瘫的传统治疗方法，包括促动力药物、空肠造口管喂养和完全肠外营养(TPN)，都有不同的局限性。许多患者对现有药物耐药，这也带来了副作用和药物相互作用的风险。空肠造口术和全胃肠外营养提供营养支持，解决胃瘫的症状，但会造成生活质量问题，并不能纠正潜在的疾病。单点、低能量电刺激，如美敦力的Enterra TM Treatment提供的刺激，通常也可以治疗恶心和呕吐的症状，而不是潜在的疾病。在一种新的动力障碍治疗方案中，多通道相控胃起搏器使用电子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，试图牵涉胃慢波，正常化胃肌电节律紊乱，并正常化胃排空。最近的研究表明，多通道起搏比以前的单通道高能起搏更有效地携带胃慢波，并且多通道设计需要更少的能量，使其更适合于长期的人类植入性治疗设备。

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.