Investigational Airway & Pulmonary
Tissue Imaging Systems

Tomophase OCTIS™ has received the FDA 510(k) clearance to market

Tomophase has developed a real-time endoscopic tissue imaging system based on its proprietary technology in Optical Coherence Tomography (OCT). The Tomophase system is designed to enable the high-resolution, real-time visualization of bronchial and pulmonary tissue cross-sections in-vivo. Its design features include:

◙ Subsurface Microanatomy Visualization (within 2-3 mm)

◙ Real-Time Operation

◙ Micron Scale Resolution

◙ Superior Image Clarity to other OCT Technologies

◙ No Radiation, UV light or Contrast Agents

◙ Sample Site Morphology Information Retained

◙ Both Forward and Side Scan Imaging (in development)

◙ Tissue Metabolic/Biochemical Information (in development)

 

The FDA cleared Tomophase imaging system is designed to operate in conjunction with conventional endoscopes. For pulmonology use, OCTIS is compatible with the working channels of multiple flexible video bronchoscopes and their extended working channels. To acquire images of lung tissues, the disposable imaging catheter is inserted into the working channel of the bronchoscope. The near infrared (NIR) light beam emitted from the distal tip of the catheter can then be steered to target the tissue of interest. Back scattered light is collected by the catheter and processed optically and electronically to produce high resolution, real-time and cross-sectional images of the tissues that the light beam penetrates. The figure below shows an image of the Gen2 system, which consists of the Imaging Console, PC-based processor and catheter. The Image on the right shows the disposable catheter protruding from the bronchoscope working channel.

With the Tomophase OCTIS system, airway and tissue cross-sections can be visualized in greater detail than with other currently existing imaging tools. Its optical resolution is on the order of microns, which would be 10-100 times better than other imaging technologies such as ultrasound and computed tomography (CT) [resolution on the order of 0.2-2 millimeters, respectively]. Using our real time imaging system, it is now possible to visualize micro-anatomic features such as airway epithelia, mucosa, and the smooth muscle layer both in-vivo and in-situ.  The figure below shows screen shot of the OCTIS system. The video image from the bronchoscope is seen in the upper right corner. On the left, we show the cross sectional image of the airway corresponding to the location shown in the video image. The ability to visualize airway microstructure is a breakthrough for the Interventional Pulmonologist.

In the near future, Tomophase will be adding spectral absorbance mapping in the imaged cross-sections. Spectral absorbance (SA) is the basis for one of the most successful medical devices, i.e. the pulse oximeter. Various other SA features can be related to biochemical and metabolic activities of living tissues. Tomophase imaging will be configured to utilize a differential SA tomography (SAT) to spatially map important spectral features on a microscopic scale. The resultant spatially resolved SAT maps could potentially reveal the level of biochemical and metabolic activity of the pulmonary tissue under examination, providing valuable information to physicians. This information may be important in the case of early stage lung cancer as it may help identify tumors with high metabolic rates.

Future Potential Applications in Pulmonology

Tomophase OCTIS™imaging system has potential pulmonary applications where real time, in-situ tomographic microanatomy visualization are beneficial. These applications include:

◙Tomophase is interested in discussing clinical collaborations
in these and other areas. ◙

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