SBIR-STTR Award

The project involves the design and construction of a prototype multi-channel phased gastric pacemaker. This device offers a new therapeutic approach for the treatment of gastric motor disorders. Traditionally, the following methods are used to treat patients with gastric motor disorders: 1) medication therapy - The prokinetic agents, metoclopramide, erythromycin, cisapride and domperidone, are used to treat these patients. However, there are a number of patients who are refractory to these therapies. 2) Nutritional support - using total parenteral nutrition or tube feeding via jejunostomy. This only provides nutritional support and does not cure the disease: 3) surgical treatment -as a last resort, antrectomy or total gastrectomy is performed to resolve the problem or relieve gastrointestinal symptoms. Electrical stimulation of the gastrointestinal organs is a promising approach for the treatment of gastric motility disorders. These organs, like the heart, have natural pacemakers and the myoelectrical activity they generate can be entrained by electrical pacing. The successful entrainment of the gastric slow wave is believed to be essential in normalizing gastric myoelectrical dysrhythmias. Although most research in gastrointestinal pacing has involved single point stimulation, recent studies have shown that multi-channel stimulation provides better performance in terms of gastric slow wave entrainment and energy consumption.

Thesaurus Terms:
biomedical equipment development, gastrointestinal stimulator, paralysis, stomach electrical conductance, electrode, stomach emptying medical implant science

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.

Thesaurus Terms:
biomaterial development /preparation, gastrointestinal stimulator, paralysis, stomach, stomach motility /pressure biological model, biomaterial compatibility, computer program /software, computer system design /evaluation, energy source, nonhuman therapy evaluation, stomach emptying, stomach surgery biotechnology, dog, medical implant science