GI View's miniaturized, self-propelling, self-navigating, disposable endoscope
Product Description
GI View's flagship product, the Aer-O-Scope™, is a disposable, miniaturized, self-propelling, self-navigating, endoscope incorporating a CMOS camera with unique omni-directional viewing system. An electro-optical capsule is embedded in the front of a lightweight balloon vehicle, while low pressure colon insufflation with CO2 propels the balloon, causing it to glide along the ‘slippery' colon walls without forceful maneuvering.
Computer controlled pressure management, coupled with sensors in the workstation, adjust balloon size and shape to changing bowel anatomy, thus allowing the pressure-propelled balloon to find its path. The Aer-O-Scope™'s visual system provides simultaneous 360 degree viewing of the colon mucosal surface, potentially eliminating the need for continuous tip manipulation as in colonoscopy, and potentially decreasing the chance of missing polyps hidden behind mucosal folds.
The Aer-O-Scope™ provides high resolution video images of the colon inner surface that are displayed on a screen for real time viewing. These images are digitally recorded for future viewing, interpretation or consultation.
The technology behind the Aer-O-Scope™ could allow for a safe, less threatening and much less painful alternative to conventional colonoscopy with more consistent viewing of the entire colonic mucosal surface. It is less skill dependent, yet work flow efficient, potentially allowing increased patient throughput in a cost effective way.
The Aer-O-Scope™, is in final stages of development and has been successfully tested on healthy human volunteers. Recently, the company has been granted ISO 13485:2003 certification of its quality system, and received CE Marking of its Aer-O-Scope™ device. The company expects to file a 510(k) with the FDA and to commercially launch the Aer-O-Scope™ by the second half of 2008.
Special features
The technological advances brought forward by the Aer-O-Scope™ could potentially pave the way to higher patient compliance and increased clinical throughput.
Semi-automated, colonic intubation and withdrawal via physician controlled, self-propelled and self-navigating motion technology
The Aer-O-Scope™ vision system is based on an electro-optical capsule embedded in a moving balloon with its optical dome protruding from the front of the balloon. Low pressure CO2 propels the hydrophilic coated balloon vehicle as it glides over the colonic mucosa . Monitored by a set of pressure sensors and sophisticated computer algorithms, the balloon's size and shape are continuously adjusted to accommodate the shape and size of the colon, thus making motion more efficient as well as allowing it to navigate its path through the tortuous bowel. The balloon may move forwards and backwards at the operator's will.
Intra-colonic pressures exerted by the Aer-O-Scope™ are comparable to those observed during CT Colonography. Three independent overlapping safety pressure relief mechanisms ensure patient safety.
Direct, simultaneous 360 degree viewing of the mucosal surface that holds the potential for increased sensitivity
The Aer-O-Scope provides gastroenterologists 360 degree circumferential (omni-directional) direct optical inspection of the colonic mucosa in front, behind and to the sides of the electro-optical capsule, avoiding the need for continuous tip manipulation. The Aer-O-Scope's vision system allows viewing of both sides of mucosal folds thus potentially contributing to increased sensitivity. The images from the colon are received, processed and displayed on a PC monitor for real-time high definition viewing as well as digitally recorded on DVD allowing for later “off-line” evaluation.
Patient Comfort for Improved Patient Compliance
Owing to the ultra flexible design of its supply cable and the conformity of its unique balloon, Aer-O-Scope™ introduces a new standard of patient comfort. Initial clinical tests suggest that patient tolerance to colonoscopy could be greater with Aer-O-Scope™
Avoiding cross contamination
Aer-O-Scope™ is designed with a low cost disposable module, encompassing all parts that could come in contact with the colon or bodily fluids, to substantially decrease the risk of cross-contamination. By using a disposable module, the associated costs of cleaning and disinfecting the scope are avoided as well.
Increasing clinical work flow efficiency
Aer-O-Scope™ introduces a level of automation that is expected to increase endoscopic throughput. The potentially diminished need for sedation could improve work flows and increase patient compliance. Patients presenting with lesions can be referred for same day interventional colonoscopy.
Compact & Portable The Aer-O-Scope™ control unit is designed for compact storage and portability, requiring no special infrastructure for operation, maintenance or storage.
A Multipurpose PC Workstation
A multipurpose workstation provides the user interface needed to control the Aer-O-Scope™'s motion through the colon. The workstation also receives and processes data transmitted from the digital camera attached to the scanning device, displays this data on the computer screen and digitally record it for future viewing and interpretation.
The workstation is based on PC architecture. It supplies the disposable Aer-O-Scope™ device with air, suction, water and low voltage current via the flexible sidearm that protrudes from one side of the workstation.
For operator convenience, the control panel is located at the distal end of the sidearm, providing an intuitive set of control buttons for controlling the Aer-O-Scope™'s motion. GI View's second-generation work station is a new, modular configuration with powerful features that improve physician comfort and work flow. Its modular configuration was designed to fit into any type of practice, hospital, ASC and office, reducing or completely eliminating floor-space requirements, thus significantly cutting necessary infrastructure investments.
A unique vision system
The small electro optical capsule contains a CMOS camera and provides an advanced vision system with two simultaneous scanning views.
A standard front view shows the forward path of the Aer-O-Scope™ in a manner similar to current endoscopic devices.
A unique OmniView lens that captures a 360 degree panoramic view of the colon walls, filming both ahead and behind the scanner device. The OmniView mechanism could enable detailed inspection of the entire colon surface, including those areas behind mucosal folds where hidden polyps may exist.
The electro optical capsule is embedded within a thin, low pressure balloon except for its transparent optical dome that protrudes from the front of the balloon. The balloon volume and pressure are controlled by an advanced computer algorithm installed in the workstation. A specially designed rectal introducer allows the gentle introduction of the scanning device into the rectum. The supply cable is threaded through the rectal introducer with the tip of the electro optical capsule protruding from the front. The rectal introducer has a silicon balloon to anchor it inside the rectum during the endoscopy, as well as to seal the anus and thus prevent air (CO2) leakage.
