How are you influencing cardiovascular devices?
R&D Manager, Hoowaki LLC.
Hoowaki LLC is making cardiovascular devices easier to insert and remove from the body. We modify the surface of extruded or molded devices by forming engineered surface microstructures. The microstructures reduce the sliding coefficient of friction in dry or lubricated regimes and reduce stick-slip. Our surfaces do not add materials, coatings, or fillers to the device. Hoowaki microstructures may be combined with a lubricant for a synergistic effect. Our surfaces are formed directly on the device’s base material. In friction testing of Nylon, HDPE, silicone, and FEP against a stainless steel surface, our low-friction surfaces show up to a 63% reduction in friction compared to conventional surfaces. Hoowaki provides these surfaces to device manufacturers either by modifying the extrusion die or molding tool with the negative of our low-friction surface. The surface then transfers directly to the final product during a typical extrusion or molding process.
Richard M. Rots
Software Account Manager, Dimensional Control Systems
When a manufacturer picks up a cardiovascular device, they literally hold someone’s life. There is no room for flaws in the quality of this product, or any other in the cardiovascular realm. These devices are shrinking, while becoming increasingly advanced—more intricate parts achieve more complex functions, within a surface area that leaves only enough space for perfection. So the case has never been greater for quality assurance. Conducting risk analysis through variation analysis software can satisfy it.
Variation analysis software, such as Dimensional Control Systems’ 3DCS, can help by providing risk analysis. 3DCS, a simulation tool, uses variation analysis to ensure accuracy in design that meets defined quality goals, and also cost requirements, within manufacturers’ capabilities. The 3D modeling system visually depicts variation in design and statistically simulates production of virtual assemblies. Optimizing variations in this way deters risks early on, ensuring solid function and fit, among other characteristics.
When engineers and manufacturers have a strong variation analysis system in place, it relieves some of the pressure of the demanding cardiovascular sector. Then they can view high quality as not a goal, but a standard. And when they hold someone’s life in their hands, they can do so with confidence.
VP Sales and Marketing, Interface Catheter Solutions
Interface Catheter Solutions is leading balloon innovation in several ways: 1) Decreasing manufacturing cycle times with our new “High-Efficiency Water Jacket” that also improves balloon quality and consistency, 2) Automated balloon inspection process to a minute or less for full dimensional and defect inspection, and 3) Optimized balloon extrusion Interface spent three years developing that is guaranteed to increase balloon yields.
President, Aberdeen Technologies
Aberdeen Technologies is regularly called upon to provide solutions for difficult and challenging cardiovascular devices that require insert molding technology. In 1984, founder John Schmitz helped design and manufacture one of the first molded multi-lumen catheter manifolds, which gave vascular access for multiple medium including fluids and guide wires through a single entry point. This was accomplished by using stainless steel mandrels to connect multi-lumen tubing to individual extension lumens via a molded manifold with internal non-communicating passageways. Over the years, this process has been refined and expanded to include up to six passageways in a variety of shapes and profiles. This technology is a cornerstone in the manufacture of CVC catheters that proliferate the market today. Aberdeen is often presented with challenges to accommodate smaller tubing FR sizes with micro passageways and exotic internal lumen geometries, which opens the door for more localized and specialized cardiovascular procedures.
Program Manager - Micro Processing, TRUMPF
Manufacturing stents is an important area of medical device manufacturing. The standard method for processing stainless steel (and to some extent, Nitinol) stents is fusion cutting where cutting kerfs are typically 10 to 20 µm. As newer, ultra-short-pulse picosecond lasers in the green wavelength are utilized—such as the TruMicro Series 5000 lasers from TRUMPF—processing a wider range of materials becomes possible.
These TruMicro picosecond lasers vaporize materials using up to 60 Watts of power in the green wavelength. With short pulses of less than 10 picoseconds, this is achieved with no heat-affected zone (HAZ). This cold cutting process eliminates residual heat in the material and allows manufacturers to cut not only traditional metal stents, but also polymer and other nonmetal stents with perfect edge quality. This is a truly enabling technology because it removes the need for manually post-processing.
Hand finishing stents is a highly expensive process. This is especially true of stents made of Nitinol, a shape-memory alloy comprised of 50% nickel and 50% titanium. As more ultra-short-pulse lasers are implemented, this time consuming and labor-intensive procedure will be a thing of the past.