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Laser Scanning Helps Validate Design of New Venous Filter

Laser scanning helped a medical device manufacturer validate the design of a new venous filter by ensuring that the computer aided design (CAD) geometry used as the starting point matched a molded part that had been proven safe in the field. The problem was ensuring that the as-built geometry of the existing arterial filter actually matched the complex CAD geometry that the company planned to use as the starting point for the new design. The medical device manufacturer contracted with a laser scanning service bureau to generate millions of points of data from the as-built product, align the point cloud to a CAD model, and generate a color deviation report between the surface model and the CAD geometry.

 

Re-using geometry for new filter product

Veins carry blood from all organs of the body back to the heart. There are a number of conditions that can occur as a result of localized inflammation and clotting of veins, particularly in the legs. Deep vein thrombosis is the term often used for a blood clot that develops in the deep veins of the legs. This is a potentially dangerous condition because there is some risk that a part of the clot can break loose and travel in the blood stream to lodge in the lung, which is a condition known as a pulmonary embolus. The mainstay of treatment is anticoagulant therapy using coumadin or heparin.  However, in selective circumstances, a venous filter is placed to prevent blood clots from reaching the lung.

The geometry of the new filter is based on the design of an arterial filter that has been on the market for some time and has been proven to be both safe and effective. Engineers wanted to take advantage of this experience by duplicating much of the flow path geometry from the earlier arterial filter design in the new venous filters. This can be done easily by scanning the existing flow path geometry and extracting IGES curves from the triangulated point cloud in the form of an STL file for use as a template in creating the new filter geometry.

Challenge of validating CAD model with as-built product

But the engineers realized that the complexity of the flow path geometry meant that they could not be certain that the computer aided design model that they intended to re-use in the venous filter actually matched the molded part that had been proven in the field. They had complete confidence in the molded part because it worked fine in the market. But the geometry was so complex that there was no way that they could be sure that it matched the original CAD model. They thought about inspecting the part with a coordinate measuring machine (CMM) but realized that the number of points that would be required to fully validate the 3D surfaces was far more than it would be practical to capture using one-point-at-a-time contact methods.

Fortunately, the technology of laser scanning has emerged in recent years to present a viable alternative. Laser scanners work by projecting a line of laser light onto surfaces, while cameras continuously triangulate the changing distance and profile of the laser as it sweeps along, enabling the object to be accurately replicated. They collect thousands of points every second at a high level of accuracy so they are able to accurately digitize complicated parts. The elimination of the need to maintain contact with the workpiece also means that the results are independent of the skill of the operator.

With a relatively small number of parts that need scanning every year, engineers felt that it didn’t make sense to rush into a purchase of a machine. So they looked for a service bureau that could provide the high accuracy and fast turnaround the company needed on nearly every project. They talked to three different companies and selected the GKS Inspection Services division of Laser Design Inc because they not only understand laser scanning technology but they also understand part inspection and were ready, able and willing to help them through the entire process.

Laser scanning provides fast and economical solution

The engineers emailed the CAD geometry and shipped the physical part to GKS Inspection Services. GKS then scanned the part, generating a point cloud with the millions of points needed to accurately define the complex surface geometry of the part. GKS then generated a graphical comparison of the manufactured part vs. the CAD model, while coding differences between the two in colors that indicate the magnitude of the variation from the design intent. Being able to see the differences in 3D made it much easier and faster to compare the parts. The engineers were able to instantly visualize the differences between the model and the molded part. They asked GKS to rescan several areas that were critical at a higher level of resolution. Based on these scans, engineers made a number of modifications to their CAD model to match it more perfectly to the actual as-built part. The entire process of scanning the part and developing the difference map took only about one day plus the time of shipping the part to GKS. The cost for the Inspection Process of scanning and comparing back to the CAD model was minimal and the turn around was much faster than normally expected for conventional CMM touch probe based measuring yielding uncertain results.

When you are re-using existing design geometry, it’s a good time to stop and ask whether or not the geometry that you are re-using actually matches the product that has been proven in the field. This question is particularly important when you are dealing with medical devices. This application demonstrates that laser scanning provides a fast, accurate and economical method of validating the geometry of even the most complex geometries.  The new venous filter has since gone into production and has proven just as safe and effective as its predecessors.

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