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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44DK058487-02
Application #
6693878
Study Section
Special Emphasis Panel (ZRG1-SSS-3 (10))
Program Officer
Densmore, Christine L
Project Start
2000-09-15
Project End
2005-07-31
Budget Start
2003-08-15
Budget End
2004-07-31
Support Year
2
Fiscal Year
2003
Total Cost
$305,196
Indirect Cost
Name
Virginia Technologies, Inc.
Department
Type
DUNS #
096348581
City
Charlottesville
State
VA
Country
United States
Zip Code
22911