USA flag logo/image

An Official Website of the United States Government

A Multi-Channel Gastric Pacer for Treating Gastroparesis

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
66329
Program Year/Program:
2003 / SBIR
Agency Tracking Number:
DK058487
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
VIRGINIA TECHNOLOGIES, INC.
660 Hunters Place CHARLOTTESVILLE, VA 22911-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2003
Title: A Multi-Channel Gastric Pacer for Treating Gastroparesis
Agency: HHS
Contract: 2R44DK058487-02
Award Amount: $730,429.00
 

Abstract:

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.

Principal Investigator:

Robert A. Ross
4349702200
ROSS@VATECHNOLOGIES.COM

Business Contact:

Robert Ross
8049702200
ROSS@VATECHNOLOGIES.COM
Small Business Information at Submission:

VIRGINIA TECHNOLOGIES, INC.
VIRGINIA TECHNOLOGIES, INC. 2015 IVY RD, STE 423 CHARLOTTESVILLE, VA 22903

EIN/Tax ID: 541785431
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No