As engineers and medical professionals continue probing for improved products to boost patient care, they face the daunting challenge of getting new concepts to manufacturing reality. Often, the ideas are there to tackle a specific problem or issue but not the manufacturing know-how.
For Zeus, meeting such challenges is its strength. One of the company’s guiding principles is to innovate and lead with new products and designs to address application needs just like these.
Performance catheter components
A core element of Zeus performance extrusions for the medical industry is its components for catheter construction. FluoroPEELZ peelable fusing sleeve vastly improved the removal process after the reflow step of catheter construction. LCP monofilament is an MRI-compatible non-metal braiding material and Zeus’s polytetrafluoroethylene (PTFE) base liners are the thinnest available for use as a free extrusion.
Now, adding to these is Zeus’s new tie layer – a thin polymeric coating applied to the etched OD of the PTFE liner designed to reduce delamination and improve mechanical attributes of the finished catheter shaft.
Catheter tie layer – continuing innovation
This new tie layer represents a significant step forward for catheter construction. The tie layer is applied as a coating to an etched PTFE extruded liner – a process unique to Zeus. Applied in this way, the tie layer promotes more uniform adhesion of the reflowed jacket to the etched PTFE liner.
Secondarily, the tie layer will typically be of a similar or same material as the jacket, creating a like-for-like bond during jacket reflow. With the tie layer bonded to the liner during the coating process, the summary effect of the tie layer is to increase the liner-to-jacket bond strength. Preliminary testing has shown that the tie layer increases linerto- jacket bond strength up to two-and-ahalf times compared with catheters made without it. Depending on the material and durometer chosen, the tie layer has been shown to improve catheter performance, deliverability and increased column strength.
The tie layer’s most important advantage is safety. The increased layer bond strength of catheters made with the tie layer addresses the serious safety concern of delamination – the separation of layers within the catheter. Aside from delamination defects discovered during final inspection – the most costly yield loss and a major contributor to raising production costs – it carries high liability of delamination problems occurring in a clinical environment. There, delamination failures have direct repercussions for patient safety. The increased bond strength from the tie layer also supports a more mechanically consistent device with more reliable performance characteristics.
These attributes lead to more efficient catheterisation procedures and lower risk to patients.
Tie layer – versatility and safety
The tie layer is versatile and suitable for a variety of applications, and can be produced in a variety of durometers. While currently offered in a variety of materials, including Pebax, nylons and polyurethanes, Zeus will also continue to make tie layers available in other materials.
In keeping with its history of leading the way, Zeus has identified a tie layer to be an ideal solution for those catheter manufacturers wanting to secure a PTFE liner to the ID of a metallic tube, such as a laser-cut hypotube. This versatility afforded by the tie layer allows device designers and makers to precisely tailor the performance of their device to deliver life-saving therapies in some of the most tortuous vascularture.
With industry buzz words like ‘continuous improvement’, Zeus catheter componentry is advancing this industry. And, as exemplified by the tie layer, any improvement to manufacture, design or device implementation will undoubtedly result in improved patient safety.
