DIRECTVIEW™ ENDOSCOPIC PRODUCTS
DirectView™ DIVA Laparoscopic System
MITI’s FDA-approved DirectView™ DIVA Laparoscopic System consists of a unique 4 lens laparoscope (in lieu of the 26 lenses now necessary for a conventional scope) that is used with disposable, interchangeable, angled LightGuides. Because of their unique construction, our DIVA Laparoscopes offer additional advantages of low heat, electrical conductivity and ease of sterilization, at significant less cost, without either changing the use of the device or compromising its application.
DIVA 10mm Laparoscope
Our FDA-approved DIVA 10mm Laparoscope eliminates the eyepiece and endocoupIer while providing a superior image connecting directly to your camera. This laparoscope is far from "conventional," using only 4 lenses in lieu of the standard 26 to achieve image quality.Its incorporation of disposable interchangeable viewing angles eliminates the need for the surgeon to utilize several different angled scopes in the OR to acquire a complete field of view. This pre-sterilized laparoscope is targeted at new FDA requirements that limit the use of re-processed endoscopes. Priced under current market cost, DIVA Laparoscopes effectively offer a new, affordable instrument for each surgical procedure.
DIVA LightGuides
Our FDA-approved, pre-sterilized, disposable, interchangeable DIVA LightGuides are used with our DIVA Laparoscope and provide illumination that transits the length of the device. They also provide a sterile barrier that allows the camera to be used for multiple procedures without being re-sterilized. Opened just prior to surgery, the LightGuides also provide a sealed completely sterilized interface at the time of use. They not only reduce the potential for infection at surgical sites, but enable the surgeon to utilize only one scope in the OR instead of two or more in order to acquire a full field of view with 0, 15, 22 and 30 degree interchangeable angles. This eliminates the need for separate, expensive instruments for alternative views.
DIRECTVIEW™ PIPELINE PRODUCTS
DIVA Conversion Adaptors
Our DIVA Conversion Adaptors converts competitor’s laparoscopes to the MITI DIVA System. The Conversion Adaptors will be offered in 0, 15, 22 and 30 degree angles as well as custom angles on an individualized basis. Like the DIVA LightGuides, The Conversion Adaptors can also be rotated a full continuous 360 degrees. They utilize the DIVA LightGuide technology, sliding over the outer diameter of the conventional laparoscope, and are secured at the proximal end of the device. An integral prism system and illumination extender at the distal end interfaces with the objective lens of the laparoscope to channel the image from the off-axis angular position into the optical telescope system and displays the image on a medical video system in the usual manner. The LightGuides will be available to fit with the individual original manufactures products.
DIVA Colonoscope/GI Endoscopes
Our DIVA Colonoscope/GI Endoscopesl incorporates “chip on a stick" technology with its proprietary, pre-sterilized disposable, LightGuides. These flexible endoscopes will be 5mm in diameter, 800mm in length, and designed for colonoscopy and gastro intestinal applications in the office or clinic. Unlike fiber optic imaging systems, the MITI system utilizes an articulated subminiature camera located at the endoscope's distal end to obtain high quality images. The DIVA LightGuide provides a sterile barrier that allows the camera to be used for multiple procedures without being re-sterilized.
DIVA 5mm Rigid Endoscopes
Our DIVA 5mm Rigid Endoscopes combine a our unique 4 lens optical system with our DIVA LightGuides and .are essentially be a downsized version of the 10mm laparoscope. This 5mm diameter endoscope will employ articulation control integrated into an ergonomic handle. The small diameter will provide the ability to reach into smaller regions of the anatomy to acquire images from areas that may be inaccessible to rigid endoscopes. The overall ergonomic design is also similar, with the light cable positioned the same was as the larger device. This design will also be available with or without the eyepiece.
DIVA 5mm Semi-Rigid Endoscopes
Our Semi-Rigid 5mm Endoscope uses an embedded “chip-on-a-stick” camera system at the distal end of a 5mm endoscope combined with opre-sterilized LightGuides.. This unit is 300mm long. This allows the endoscope to be directed from its distal end, of which, 100mm can be articulated. The articulation expands the field of view, and allows the instrument to be maneuvered into very tight places in the body. A convenient hand control enables the surgeon to manipulate the distal tip with 4 degrees of articulation. The 5mm endoscope uses a miniature camera with 540 X 480 pixels and an extremely efficient optical system. The small size of the embedded camera and objective lens system provides excellent optical performance without the use of relay lenses and/or rods normally associated with conventional instruments. . In order to allow the endoscope to be guided with minimal force, this flexible material, as well as that of the electronic cable which carries video information, is designed to offer little resistance. The combination of the instrument’s small diameter, the LightGuide’s flexibility, and the unique articulation system permits the endoscope to be safely maneuvered.
DIVA Diagnostic Medical Office System
Our DIVA Diagnostic Medical Office System includes a video monitor, light source, disposable endoscopes and computer-based digital camera system.. Convenient flash memory, CD or tape capability provides archival storage. This system is designed to be compatible with all current endoscopes; however, used with DirectView endoscopes, the combined system offers additional advantages of disposability, convenience and lower cost. Although they can be purchased separately, when combined as a package, the system’s individual components provide enhanced capabilities not available elsewhere. In addition, the digital system integrates a patient’s history, diagnostic and surgical history, and surgical images, storing them in the computer’s data base.
DIVA Multispectral Light Source
Because current cameras require a continuous light output to illuminate the body cavity in order to “see” images through the endoscope, they lack this capability. In contrast, the DIVA Multispectral Light Source is “pulsed” and dynamic, with 10 microsecond pulses of light being generated once every thirty milliseconds. The time in -between the pulses which generate light for imaging can be used to project ultraviolet light waves for therapeutic intervention. The MITI camera system functions in this dynamic mode to deliver 30 video images a second. The DIVA Multispectral Light Source contains practical features that make it particularly effective for use in the OR.. Conventional light sources generate significant heat (enough to smolder paper drapes used for patient coverings; and sufficiently hot to burn a surgeon’s hand on the fiber optic connector on the endoscope; and can cause unwanted blood coagulation if placed too close to a surgical area. Furthermore, these light sources have an operational lifetime of only a few hundred hours; lamp burnout out during a procedure can cause serious problems. In contrast, the life of MITI’s pulsed light source is rated for up to nine years of typical use before replacement is necessary.
DIVA Digital Imaging System
Our computer-based DIVA Digital Imaging System is the basic building block for all our products. This system includes not only a digital camera, but, also, a computer system that captures camera images from within the body cavity and displays them on a video monitor. The system captures high resolution images and displays them on surgical monitors. The computer directly interfaces to a remote camera, which, in turn, connects to our DirectView and TheraScope endoscopes. This system can be used with all current conventional endoscopes, light sources and video monitors. Our DIVA Imaging System is compatible with all video monitor formats including NTSC, PAL, VGA, DVI and HDTV. Future therapeutic capability is built into all our imaging systems to permit photo reactive, photo microbial, photo fluorescence, photo dynamic and laser therapy when activated. This additional capability works in tandem with our Multispectral Light Source to perform therapy.
THERASCOPE RESEARCH TECHNOLOGY
Our Endoscopic PhotoMicrobial Therapy has conclusively demonstrated in the laboratory this technology’s ability to destroy bacterial organisms such as MRSA 300 with lightwaves in a matter of seconds. Our kill rate is 100%. This new capability could provide the patient with better healthcare and greater safety, and surgeons with additional revenue.
This technology can be adapted to a Hand Topographical Scanner that can sweep open wound and surface trauma in a doctor’s office. The device will eradicate bacteria from burns, cuts and wounds with no tissue contact within seconds of lightwave exposure. The product will be designed for hospitals, clinics, doctors’ offices, but could also seriously augment EMT and ambulance capability. .A Therapeutic Catheter System is also being designed to eradicate Pathogens which infect a patient’s blood and/or bladder catheters as well as breathing tubes. Because of extended use, these devices are subject to serious MRSA foreign body infections.
Our proprietary, therapeutic, technology, TheraScope™ combines digital imaging with therapeutic intervention into a single endoscopic device, thus harnessing the spectrum to “heal with light waves. The Therascope™ combines lightwave therapy to which the pathogens have no defense and endoscopic imaging. Its objective is to direct lightwave therapy to either a localized area within the body, or onto external surface tissue to destroy antibiotic-resistant infectious bacteria.
This technology is targeted at antibiotic-resistant infection, foreign body reaction or a disease state such as cancerous tumors. Surgeons will be able to both image and intervene therapeutically using a single device. Specifically, they will be able to sweep the bacteria-killing endoscope over diseased tissue, including trocar ports, before closing, to eradicate or greatly diminish the potential for bacterial infection. This physical technique may be used to supplement, or even replace traditional drug therapy.
Our Therascope also couples traditional imaging with a new therapeutic capability, Endoscopic PhotoReactive Therapy. MITI is now developing specialized rigid and flexible endoscopes using lightwaves to activate photo reactive anti-cancer agents and diagnostic dyes that show differential adhesion to tumors. These photo reactive dyes can be activated by the TheraScope after injection into human tissue, generating images which cannot be viewed through a conventional endoscope.
Our Laser-directing Endoscopes will be designed to integrate therapeutic lasers with a target-marking capability analogous to weapons systems which shine beams of light on a target within the body. The laser directing endoscopes are expected to be able to direct invisible laser energy through our endoscopes to the area of ablation. The target image created by the endoscope is projected as an overlay on the monitor with a video image created by the endoscope.
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