Israeli firm develops tool to guide ultrasound biopsies

UltraGuide showcases technology at AIUM meeting

An Israel-based medical device company has developed a new interventional tool for ultrasound-guided biopsies that it hopes will make mediocre interventionalists good and good interventionalists better. UltraGuide introduced its technology, called UltraGuide 1000, at the American Institute of Ultrasound in Medicine meeting in Boston in March.

UltraGuide 1000 is a Pentium-based, PC-driven peripheral that guides and then tracks the path of a biopsy needle to lesions. These lesions can be in any part of the body visible with ultrasound, including the breast, abdomen, and thyroid. The device was cleared by the Food and Drug Administration in February and is priced at about $45,000.

Perhaps the most important aspect of UltraGuide 1000 is its ability to register the biopsy needle in line with the target even before the needle penetrates the skin. The device does so by using position sensors, one affixed to the needle, the other to the transducer. Positions in 3-D space are put in the context of 2-D gray-scale images.

"The system recognizes the image on screen and overlays graphics that tell how to position the needle in and out of the plane even before it is inserted, " said Dov Gal, director of operations and clinical marketing for the company, which is based in Tirat Hacarmel.

UltraGuide 1000 hooks into the output jack of an ultrasound scanner and is a simple and elegant solution to the need for precise positioning in ultrasound-guided biopsies, according to the company. Images indicating the location of the biopsy needle may be shown on the scanner monitor, but physicians will likely use a separate viewing station. One of the advantages of the peripheral station is a voice-recognition feature that allows voice control over how the data are presented on screen.

In either case, algorithms begin by translating the data into a bird's-eye view from the top of the probe. Blue lines radiating from the exterior of the patient show an interventional glide path to the lesion, much like an aircraft guidance system plots the route to an airport runway. On-screen guidance continues as the tip of the needle comes into the plane and then pierces the patient's skin.

At the AIUM conference, a demonstration of the system was accomplished on the exterior of a tissue-equivalent phantom. Distance to the lesion could be seen on the monitor. In the demonstration, the lesion moved upon needle contact, was pierced, and finally pulled back along with the needle upon its withdrawal.

UltraGuide 1000 is simple to operate, according to the company. Setup is no more difficult than clipping position sensors to the needle and transducer, placing a magnet that provides a reference field for determining 3-D space locations within a few meters of the patient, and picking up the transducer and needle.

"These are positioning sensors that know the relationship of one to the other, " said Gal. "The positioning system is incorporated into the machine, as well as the algorithms that allow you to see this graphic display and to calculate exactly where the data is in space. "

Clearly, UltraGuide serves a function in today's 2-D practice of ultrasound, in which flat planes of ultrasound data bear little connection to intuitively recognizable anatomy. Its utility has been documented, according to Gal, by luminary studies at several U.S. institutions, including Thomas Jefferson University. The ultrasound community may soon see more of the product. At present, only Gal and another UltraGuide employee are actively selling the product, but that could soon change. The company, according to Gal, is looking at other options, such as using OEMs to distribute the system.