Every year, diseases of the gastrointestinal (GI) tract account for more than 30 million office visits in the United States alone. GI tract disorders are easy to cure in their early stages but are difficult to diagnose. Common exam procedures, such as endoscopy, are often not adequate and reliable. Supposedly, endoscopy is to exam the walls of the digestive tract. However, existing endoscopes are design to have a limited forward-looking field-of-view (FOV). Even with a side window to view a portion of GI tract walls, a 360? panoramic view cannot be obtained simultaneously. Subsequently, limited FOV and lack of ability to see 360? surrounding areas may lead to significant discomfort or potential damage to patients due to the need for turning entire endoscope to """"""""look around"""""""", and lead to undesirable consequence of missing potential sites of disorders, e.g. hiatal hernia, gastritis, ulcers, polyps, stomach/colon cancer. This SBIR project develops a novel 360? capsule camera, dubbed the Neo360 CapsuleTM, which provides a simultaneous panoramic 360? field of view (FOV) using optical unwrapping, instead of digital unwrapping. Xigen's proprietary Neo360 imaging technology can provide 70% more image resolution than conventional endoscopes, and employs no moving parts. Not only can it acquire 360? video of interior walls of the gastrointestinal (GI) tract, but also such 360? video images can be viewed directly, for the first time, without need of external computational hardware/software for unwrapping. The proposed Neo360 Capsule would provide endoscopists with greatly enhanced imaging performance that could eliminate certain miss-diagnosis of disease during GI exams. The directly viewable 360? video would also enhance visualization and communication in clinical practice. Xigen LLC has successfully completed a Phase I investigation on the Neo360 CapsuleTM design and demonstrated convincingly the feasibility of this novel imaging technology via theoretical analysis, software development, simulation validation, CAD design, prototype fabrication, and bench-top experiments. Phase II program will design and build a functional prototype of the Neo360 CapsuleTM, test the prototype by technologist and clinicians, and pursue various commercial applications.

Public Health Relevance

The proposed Neo360 CapsuleTM concept blazes an entirely new trail in the 360? imaging technology field. It will greatly increase the efficiency, accuracy, and patient's comfort in GI tract diagnosis and treatment. It will also provide a unique tool for documentation, surgery planning, and training. Due to its simple structural and optical design, the Neo360 CapsuleTM can be manufactured at low cost with high reliability for practical field use environment. The Neo360 imaging technology developed under this SBIR program is a """"""""platform technology"""""""" with widespread commercial potential. As a breakthrough imaging technology, it will lead many researchers and practitioners to rethink the way video images are captured and spawn commercial ventures to bring it to clinical markets. In addition to many medical diagnostic instrument applications, e.g, endoscopes, gastroscope, cystoscope, colonscope, etc., the Neo360 imaging technology will lead to commercial applications in many other areas, such as pipe inspection, turbine engine diagnosis, video surveillance, automotive safety devices, navigation, security, mobile robotics, video conferencing, and internet webcast. Xigen has an integrated product development and market entry strategy. Based upon our extensive market analysis performed during Phase I, we have selected three major vertical markets in which to develop innovative product(s) offering significant value propositions. These three vertical markets are: (1) medical and industrial endoscopes (~$4.3 billion);(2) video surveillance cameras (~$13 billion), and (3) automotive safety products, e.g., rearview mirrors and parking sensors, (~$13.4 billion). Key Words: Capsule endoscope, 360-degree imaging, panoramic view, unwrapping, medical imaging.

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 #
2R44DK079368-02
Application #
7664081
Study Section
Special Emphasis Panel (ZRG1-DIG-E (10))
Program Officer
Densmore, Christine L
Project Start
2007-09-06
Project End
2011-04-30
Budget Start
2009-05-01
Budget End
2010-04-30
Support Year
2
Fiscal Year
2009
Total Cost
$369,623
Indirect Cost
Name
Xigen, LLC
Department
Type
DUNS #
556593791
City
Rockville
State
MD
Country
United States
Zip Code
20852