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Biomedical Application Case Study -
Medical Device Research & Development

Boston Scientific
Saving Lives at 40,500 Frames per Second

"The Kodak EktaPro HS motion analyzer, model 4540 [Note - Redlake MASD, Inc., has acquired the Motion Analysis Systems Division From Eastman Kodak and the model 4540 is now the Fastcam Ultima 40K] has become one of the mainstays of Boston Scientific’s R&D department because it has helped the company save money, reduce production time and deliver a more efficient product. By combining a high-speed camera from Kodak and our design engineers’ expertise, Boston Scientific has developed a tool to help reduce the risk of heart disease resulting from plaque buildup."   (The Redlake MASD Fastcam Ultima 40K was replaces with the MotionPro PCI camera).)

Kevin Reed  
Senior Engineering Technician  
Boston Scientific  

Excessive Plaque Buildup Doesn't Mean a Death Sentence
Heart disease affects over 13 million Americans, killing almost 500,000 of them each year. While there are many causes, heart attacks, strokes, and damaged tissue can all occur when arterial plaque buildup goes undetected. Thanks to today’s medical advances combined with sophisticated tools to design life-saving products, excessive plaque buildup does not automatically translate into a death sentence.
     Boston Scientific’s Northwest Technology Center in Redmond, Wash., manufactures a product, the Rotablator® Rotational Atherectomy System, that is designed to remove plaque from arterial walls using a tiny football-shaped burr that spins its way through the plaque to disintegrate it. Each hand-made burr is 1.25-2.50 mm in diameter, is coated with microscopic diamonds, and spins at speeds up to 200,000 revolutions per minute (rpm) to grind away the plaque deposits.
     Precise motion analysis is a key component of the R&D process at Boston Scientific. Engineers use a high-speed motion analyzer from Kodak to help design and enhance the company’s plaque-eating Rotablator Rotational Atherectomy System. This analysis has been instrumental in developing multiple generations of increasingly effective burrs. Additionally, the use of a motion analyzer has reduced development time and cut costs.

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Precise Motion Analysis
Engineers use the Kodak EktaPro HS motion analyzer, model 4540, as an integral part of the research and development process at Boston Scientific. The camera is used to study the rotation of the burr and the motion of the drive shaft that connects the burr to the turbine in the device. R&D engineers also use the camera to analyze concepts for new shapes of burrs and rotating parts. By analyzing the motion of the burrs, engineers can develop more effective ways of removing the plaque deposits.
     The burr is connected to a turbine and bearing assembly which rotates at speeds up to 200,000 rpm, giving the burr a surface speed of about 65 mph. The high-speed camera makes it possible to see aspects of the Rotablator catheter’s motion at work, from proper spinning motion to damaging lateral motion or vibration, at a variety of slow motion speeds.
     The Rotablator catheter’s turbine can drive a cyclic oscillation that causes a wavy snake-like motion in the catheter driveshaft. This can’t be monitored by the naked eye. The Kodak high-speed analyzer, however, allows engineers to see how long a vibrational mode is on a drive shaft and watch the movement of the spinning burr.
     At 40,500 frames per second, engineers can capture 15 images during every revolution of the burr. In this application, engineers can simulate an actual procedure, watching a specific spot on the burr come around and make contact with a simulated plaque deposit. This detailed movement of the burr can be viewed on a video monitor at a variety of playback speeds as slow as one picture per second, as well as freeze frame, to allow engineers a detailed look at the burr’s position.

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Prototype Assessment
The biggest enemy of the burr is lateral motion. It reduces the efficiency of the burr exponentially. Energy lost to vibration and lateral motion in the drive shaft does not reach the end of the burr. This lateral type of vibration will also irritate the inside of the patient’s artery.
     In one situation, a prototype burr underwent observation. To the naked eye, the burr and drive shaft seemed to operate perfectly. However, some unexplainable results occurred during the preliminary tests. Using the high-speed camera, engineers immediately discovered that the experimental shape of the burr was causing poor performance.
     The design of this particular burr was immediately scrapped. Without the use of the Kodak high-speed camera, it could have taken up to a year for Boston Scientific engineers to assess the true nature of the problem. The time savings were worth up to $1 million in research costs, one of the reasons Boston Scientific purchased a high-speed motion analyzer specifically for the R&D group.

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Ease of Use
Initial operator training takes around 30 minutes, and R&D engineers were using the motion analyzer in the laboratory very quickly. Additionally, the model 4540 motion analyzer has several useful features. Instant feedback is available from digital images stored in memory. These images can be reviewed on a monitor, downloaded to standard videotape for future reference or transferred to a PC for image analysis. The Boston Scientific set-up consists of halogen fiber lights with the subject shot at a distance of one to two feet.
     Currently, engineers use the camera on as many as 10 projects per day. Some projects require use of the camera for two to three days at a time, taking advantage of the instant feedback to change designs, and check performance of the redesigned components.
     This motion analysis system has become one of the mainstays of Boston Scientific’s R&D department because it has helped the company save money, reduce production time and deliver a more efficient product. By combining a high-speed camera from Kodak and our design engineers’ expertise, Boston Scientific has developed a tool to help reduce the risk of heart disease resulting from plaque buildup.

Kodak and EktaPro are trademarks of Eastman Kodak Company. Rotablator is a registered trademark of Boston Scientific Corporation.
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