ALGOR SOFTWARE MAKES LIFE LESS PAINFUL FOR PATIENTS UNDERGOING BIOPSIES

Graphic shows the ColorMark® device and associated biopsy image.

Helen's heart skipped a beat every time the phone rang. Her doctor told her that he'd call as soon as the lab results from her biopsy were in. Finally, he calls and says the results were inconclusive and he will have to do another biopsy. More pain and another week of waiting.

Soon, Helen and the five million others who undergo needle biopsies each year in the United States won't have to retake biopsies because of inaccurate results the first time around. That's because EchoCath, Inc. - with the help of Algor's mechanical engineering software - has developed the ColorMark® system.

Because the ultrasound machine can detect even the slightest movements, the needle's vibrations give a colored image of the needle on the screen, easily visible to the technician. ColorMark thus eliminates the problem of not being able to see the needle. Since the ColorMark system's calibrations are delicate and require great precision, EchoCath turned to Algor software to ensure the most accurate engineering of the system for real-world conditions.

Improving Biopsy Procedures

"Currently the three methods for performing needle biopsies are touch-guided, X-ray and ultrasound," said Frank DeBernardis, president of EchoCath. "Each of these methods has drawbacks for the patient. Physicians can perform some biopsies by locating the suspected lesions by touch, but touch-guided biopsies will only be accurate for lesions close to the skin surface. The touch-guided method can't be used for most breast, thyroid or organ biopsies. For some touch-guided organ biopsies, there is a substantial chance that negative biopsy results are inaccurate and that there is a cancerous lesion," said DeBernardis.

Image-guided biopsies, which use X-ray or ultrasound technology, can more accurately locate the lesion but also have drawbacks, according to DeBernardis. X-ray-guided procedures, particularly CAT scan-guided procedures, are expensive and time-consuming. While ultrasound-guided biopsies are less expensive and faster, it is often difficult to see the biopsy needle on the ultrasound screen image.

Enter the ColorMark System

ColorMark is a small device which, when attached to a biopsy needle, causes the needle to vibrate at almost undetectable levels. ColorMark is used with a color-flow Doppler ultrasonic system. A Doppler ultrasonic system projects an all black-and-white image with the exception of anything that moves in the field of the screen. These portions of the image are in color.

The most critical part of the ColorMark system is the driver. The driver causes the needle to vibrate. It works like a tuning fork: when driven, it vibrates. Unlike a tuning fork, which is designed to vibrate at the same frequency at all times, the driver of the ColorMark system vibrates at multiple frequencies due to the driver's unique shape.

Shown here is the modal analysis of the clip of the ColorMark® system. Algor software enabled engineers at EchoCath to locate the natural frequencies without having to build new models for each design change. When the clip of the ColorMark system is driven, the biopsy needle vibrates, enabling ultrasound technicians to see the precise location of the needle when performing biopsies deep beneath the surface of the skin.

Engineers used Algor software to find the optimal size and shape for the driver that would enable it to vibrate at a number of natural frequencies to accommodate various needle sizes. "We needed to know where the greatest natural frequency of the combinations of the driver and various needle sizes would occur so we could determine the range of the number of cycles per second that the system would have to generate," said Bayard Gardineer, vice president of engineering at EchoCath, Inc.

Engineers also needed to determine the natural frequencies at which a large variety of needle sizes would vibrate. Using Algor's Beam Design Editor, engineers examined these different needle sizes with various driving forces imposed on them. This information about the driver and needle frequencies, enabled EchoCath to develop an optimal design for the ColorMark system. "Designing the system required us to build dozens of models. With Algor software we avoided building hundreds more," said Gardineer. "We learned early in the process that we could trust the Algor analyses to be an accurate reflection of real-world conditions because Algor's results were usually within two percent of our real-life tests."

"Algor understands the time and monetary constraints that engineers have when analyzing their designs," said Michael L. Bussler, president of Pittsburgh-based Algor, Inc. "Algor software is the most accurate, fastest and easiest finite element analysis software available."

EchoCath, Inc. designs medical equipment for use with ultrasound equipment. The company was established by improving the use of the installed base of more than 100,000 ultrasound units to enable clinicians to perform a wide range of procedures more safely and cost-effectively than with other image-producing technologies such as X-ray, or MRI.