DirectView™ DIVA LAPAROSCOPIC SYSTEM

MITI has received FDA 510(k) approval to produce and sell our DirectView™ DIVA Laparoscopic System with our disposable and interchangeable angled LightGuides. The FDA has determined that MITI’S technology may be used by qualified physicians for general diagnostic and laparoscopic surgical procedures for visualization of body cavities, organs, and canals to perform various diagnostic and surgical procedures.

Our DirectView™DIVA Laparoscopic System consists of a unique 5 lens laparoscope that is used with our disposable and interchangeable, viewing angled Lightguides. Our disposable and interchangeable DIVA LightGuides not only reduce the potential for infection at surgical sites, but enable the surgeon to utilize only one zero degree scope in the OR instead of four in order to acquire a full field of view with 0, 15, 22 and 30 degree interchangeable LightGuides for different viewing angles.

Because of its unique construction, our DIVA Laparoscopic System offers additional advantages such as low heat generation, electrical conductivity and ease of sterilization, at significantly less cost, without either changing the use of the device or compromising its application and imaging quality.

In addition, all DirectView™ Products are targeted at new FDA requirements which limit re-processing endoscopes to only those entities that are licensed to do so. Priced well below current market cost, the DirectView™ DIVA Laparoscopic System essentially offers a new, affordable instrument for every surgical procedure without compromising instrument and image quality for the same cost as a reprocessed unit.

SURGICAL ADVANTAGES of the DIVA SYSTEM

Unique Optical Design

The DIVA Laparoscopic System is a configurable device. In its basic form, the telescope consists of an objective lens and optical relay to convey and image from the distal end of the device to a viewing eyepiece. Such units must often be cleaned during surgery, sterilized afterward, and later rebuilt after a certain number of procedures as a result of numerous autoclaving cycles as a result of lens optical coating failure. More lenses mean more coatings.

In contrast, the DIVA Laparoscopic System uses only 5 lenses to achieve the same image quality as laparoscopes with as many as 26 lens elements. Our pre-sterilized, pre-packaged DIVA Laoparoscopic System’s relative simplicity offers a more reliable and less costly design, improved functionality and ease of use in the operating room, In addition, The use our disposable and interchangeable viewing angled LightGuides means even fewer components require sterilization. Fewer components, equals fewer failures, and a reduced need to reprocess a scope.

Modular Construction

The DIVA Laparoscope is modular, in that the instrument can be purchased either with or without an eyepiece. Eyepiece viewing is essentially a “thing of the past,” as most, if not all, minimally invasive surgery is performed using a medical camera system attached at the proximal end of an endoscope. Real-time images are presented on high quality video monitors.

The DIVA Laparoscope connects directly to your camera, thus bypassing expensive add-on devices such as endo couplers, which adapt the camera to an eyepiece and provide a means of focusing and orientation.

The DIVA Laparoscope includes a simple adaptor at its proximal end to adjust focus and orientation. Its optical system interfaces directly with a camera without using eyepiece optics or an endo-coupler by means of a “C” mount connection, the same connecting method used by an endo coupler. This eliminates both a complex optical component and the requirement for its sterilization. However, for those surgeons who are more comfortable using an endo coupler, the DIVA Laparoscope is also offered with a conventional eyepiece.

The fiber optic illumination light wire connection is standard and has varied threaded and bayonet types of connectors. This connection is made at a much shallower angle for ergonomic and functional purposes.

Typically, the light cable connection is at 90 degrees to both the laparoscope and the electronic camera cable. This prevents the light cable from interfering with other surgical ports that are used for additional surgical instruments. This configuration is used with or without and optional FDA-approved “Sterile.Extender” The SE is attached to the disposable LightGuide and transits over the camera, eyepiece and endo coupler (if used) as well as the light and electronic cabling. This helps to reduce coupling losses and heat associated with the light wire connection. However, when the DIVA Laparoscope is used without the SE interchangeability is not only much easier, but the LightGuides can be rotated in a continuous 360 degrees. Furthermore, when used with the SE, the statistical life of the instrument significantly increases because of fewer sterilizations.

Disposable Interchangeable Viewing Angled LightGuides

The DIVA Laparoscopic System’s most unique feature is its ability to convert a 0 degree laparoscope to a scope with viewing angle of 15, 22 or 30 degree within a matter of seconds. The disposable and interchangeable angled DIVA LightGuides slide over the laparoscope’s shaft, perform both extending light source illumination and effecting angle conversion. During surgery, using our zero degree laparoscope, a surgeon can remove the zero degree LightGuide and interchange it with an angular one to give a 15, 22, or 30 degree off-axis viewing angle.

All else remains constant: the camera remains the same; the endo coupler (if used) remains the same; the video image remains the same. Should the surgeon find that that the 15 degree angle does not provide the proper view, he need only follow the same procedure to change to another angle.

The angled LightGuides also enable the surgeon’s to rotate the image without moving the camera, endo coupler, cabling or the instrument itself. The fully rotated LightGuide can provide a 360 degree rotational field of view of the body cavity. This eliminates potential orientation changes often experienced with current instruments.

Patient Safety

Our pre-sterilized, pre-packaged interchangeable angled viewing the DirectView™ DIVA Laparoscopic System insures that the both the DIVA Laparoscopes and the DIVA LightGuides is pathogen-free at the time of immediate use.

The sealed LightGuides are inserted over the DIVA Laparoscope only at the time of surgery, thus isolating the internal telescope and illumination system from the patient and other working instruments. MITI also offers optional LightGuides with the flexible Sterile Extender to cover the camera and endo coupler, should one be used, as well as the fiber optic and camera cabling.

Image Recovery

During any surgical procedure, a surgeon’s vision is often obscured by blood and protein. Surgeons loose valuable time trying to clean tiny recessed lenses, either on human tissue, while potentially spreading infection, or by actually removing the scope and trying to clean it externally.. In either case, image quality is significantly degraded. A new DIVA LightGuide can be substituted withn seconds, thus recovering a full clear image as if it were a new instrument.

Electrical/Electro Magnetic Safety

The DIVA Laparoscopic System uses an insulated plastic adaptor which extends the full length of the laparoscope and holds a plastic illumination extender and prism optic assembly at the distal end of the LightGuide. Because DIVA LightGuides are constructed of non-conductive plastic, the potential for a short circuit with other devices, i.e. RF scalpels which may share the body cavity during a procedure, is eliminated.

Elimination of Heat Transfer

Plastic is a poor conductor of heat, The DIVA Laparoscopic System uses disposable plastic optics that interface with the fiber optic cable, thus minimizing the amount of heat transferred at the junction of the fiber optic and the LightGuide. This is capability helps prevent potential coagulation, eliminates heat build-up within the instrument itself, and protects the patient from the risk of burns or fire from paper drapes.

SURGICAL ADVANTAGES of the DIVA SYSTEM

Instrument Costs

The Directview™ DIVA Laparoscopic System reverses the trend of rising medical costs.

The DIVA Laparoscope sells for @$999, less than the cost of rebuilding or reprocessing existing devices. At the same time, its image is equal to that of laparoscopes costing three to four times as much.

The Directview™ DIVA Laparoscopic System does not comprise image quality for reduced cost.

DIVA LightGuides are sold in pre-sterilized packages of ten. The price per individual package ranges from $35 to $75 depending on the angle of the LightGuides.

When used with the optional SE, because the entire device and LightGuide are encapsulated, the laparoscope itself does require sterilization between procedures. When not used with the SE, the instrument’s statistical life is significantly increased as fewer lens components can fail. This provides additional savings. Because an endo coupler is not required, this further reduces unit costs. Further costs savings associated with cleaning and sterilization of the endo coupler are also eliminated.

Sterilization Costs

With the use of the disposable DIVA LightGuides, sterilization and instrument cleanup costs are either significantly reduced or eliminated. Because the laparoscope is protected by the disposable LightGuide, it does not require the meticulous clean-up now essential to conventional laparoscopes. Removing and disposing of the DIVA LightGuides into an appropriate container enables the device to be autoclaved immediately. This also increases the safety for hospital technicians who may be exposed to infection from blood and protein that must be cleaned from instruments after surgical use.

The Sterile Extender allows the optical telescope to be used without re-sterilization. This increases instrument availability for use in multiple procedures such as would normally occur in an office or clinic environment. However, use of the Sterile Extender does limit use of the LightGuides’ rotational features.

Capital & Inventory Costs

Currently, individually angled laparoscopes often cost two to three times more than a zero degree scope. Although a range of angles is essential for a surgeon to acquire a full field of view during a procedure, because of this high cost, fewer such instruments are purchased by hospitals and clinics. This lack often restricts scheduling procedures when the device is unavailable. The DIVA Laparoscopic System directly addresses this problem by offering one laparoscope with many disposable and interchangeable angles at significantly lower cost than current special angled scopes.

Indirect Costs

More and more hospitals recognize the magnitude of the indirect costs associated with longer hospital stays. Every year, nearly 2,000,000 patients incur hospital-acquired infection often contracted from improperly sterilized instruments and operating rooms. Of these, nearly two thirds suffer infections that resist at least one antibiotic drug. Approximately 100,000 Americans die annually from such hospital-bred infections. Many insurance companies are refusing to pay for such stays. Our minimally invasive, pre-sterilized, disposable DirectView™ DIVA Laparoscopic System is designed to address these problems, and is targeted at new FDA requirements regarding disposability.