For many years surgical head-mounted illumination technology has remained virtually unchanged. Currently, surgeons are forced to use expensive and outdated Xenon bulb technology that requires them to be “tethered” to the light source via fragile glass fiber optics. These glass fiber optic cables are relatively heavy and cumbersome. They can range from nine to twelve feet in length and must extend from the surgeon’s headpiece, down the surgeon’s back, and across the surgical suite where they attach to a Xenon light source box. This can cause problems during surgery, including the potential for the surgical staff to trip over the extended cables. Furthermore, the weight from the headpiece and glass fiber optic cables can contribute to neck strain problems for the surgeons. Other drawbacks of the Xenon-based technology include limited bulb life, constant deterioration of the optical fibers, and high repair and maintenance costs.

When new Xenon bulbs are first installed into a system, the amount of light created by the bulb can be as much as 930 Lumens, which creates sufficient light to illuminate the surgical field. This amount of bright light is necessary to illuminate the working field and eliminate the shadows caused by the strong overhead lights in the surgical suite. Insufficient light from head-mounted illumination can fail to eliminate shadows, thus creating problems for the surgeon performing intricate and delicate procedures. Almost immediately after initial installation, Xenon bulbs begin a deterioration process that can result in weak or insufficient light after only a few weeks of use. Lumen measurement can drop to 450 Lumens, thus requiring bulb replacement. At a cost of almost $900 per bulb, the ongoing expense associated with bulb replacement can be extremely costly to a hospital or surgical facility. In addition to bulb replacement cost, there are significant costs associated with the replacement of the glass fiber optics as well. The cables are comprised of hundreds of thin glass fibers that, when bent or moved, can begin to experience small cracks along the length of the fiber. Over time, enough light can escape through these small cracks to compromise the efficiency of the fibers, thus necessitating the replacement of the entire fiber optic cable, at a cost reaching into the hundreds of dollars. The total replacement and maintenance costs for each Xenon-based system can exceed several thousands dollars during its functional lifetime.

Due to the nature of the technology, Xenon systems are not capable of generating anything except “white” light. The amount and intensity of the light can be controlled with a simple aperture, but the wavelength of light cannot be changed or modulated. The Xenon systems are incapable of producing varying wavelengths of light, or light that can be adjusted by color, to enhance or contrast the surgical or working field. This can inhibit the ability of the surgeon to identify certain structures and tissues clearly.

AMS Technology also has a solution for the physician who does procedures in his office. The physician specialty office market is considerable different from the surgical market, in that the need for extremely bright light is not as much a consideration; however, the light must be substantial for in-office surgical procedures, suturing procedures, etc. Physicians also require that any head-mounted illumination system be portable, light-weight, and cost effective. Xenon is not used in the office market due to its initial cost and the ongoing maintenance requirements. Currently, head-mounted illumination in the physician market involves headpieces that utilize simple LED technology; however, the products presently in use are quite inefficient in their delivery of adequate light and in their ability to dissipate great amounts of heat generated by LED’s.

Thus, a few medical device companies have responded by offering small LED headpieces that contain one or two LED’s mounted on the front. Due to weight and heat issues with this type of design, the current front-mounted LED headpieces are inefficient, usually produce less than 300 lumens of light, and are completely impractical for performing simple in-office surgical procedures. In fact, headpieces containing two front-mounted LED’s can actually create more shadows than they eliminate due to the fixed focal point of the directed light. If the physician eyes are not the correct distance from the fixed focal point, the light from this system will converge at a point either in front of or behind the desired field of vision, causing a problem with shadows.

There is currently a void in the market for excellent head-mounted illumination systems that can be used for in-office surgical procedures. This is due primarily to the fact that no system exists to deliver in excess of 300-400 Lumens of light unless the system employs the costly Xenon bulb technology. This void can be filled with a superior LED technology that can produce sufficient light and be cost effective as well.