Tie Layer — a novel solution for catheter construction developed by Zeus — minimizes delamination and ultimately enhances patient safety. At the time of catheter construction, this ultra-thin thermoplastic layer is applied over a catheter liner. Tie Layer develops a melt-bondable surface that enhances adhesion to the catheter jacket as well as the liner during the reflow process of the catheter construction. Tie Layer also lowers the manufacturing cost and enhances yields.
During catheter construction, delamination is a risky failure mode, which incurs a high cost and also poses risk burden for device manufacturers. Typically, it is difficult to detect until final testing — after completion of the catheter assembly — leading to significant loss of production. Delamination could also cause failures in the field, that might lead to product recalls.
The Tie Layer solution from Zeus creates a stronger bond between the inner liner and the outer catheter jacket, thereby enhancing the consistency of catheter performance and eventually enhancing patient safety. Tie Layer not only reduces the inspection needs but also decreases manufacturing costs and enhances product yield. It is a truly comprehensive solution in catheter design and manufacture.
Tie layers can be used in applications that need one surface to be bonded to the other. Tie layers enhance the adhesion among the joined layers by acting as the interface layer.
Tie layers are an extremely useful and convenient option for improving the bonding of surfaces to wire jackets or the catheter. Following are the tie layer options for catheter components:
- Tie layer-coated polyimide tubing
- Tie layer-coated PTFE over the wire (OTW)
- Tie layer-coated FEP or PTFE base liners
Tie Layer can also be applied to improve adhesion of a coated liner to a metallic tube’s ID. For that matter, Tie Layer can be applied to nearly any round substrate.
Available Tie Layer Materials Include:
- Vestamid® 75D (Nylons)
- Tecoflex® 80A and 93A (thermoplastic urethanes, or TPUs)
- Pebax®—25D to 72D durometers
Coating thicknesses could be as low as 0.0001″, or 0.0025 mm.
Catheter Construction — It is possible to apply tie layer coatings over bondable substrates like extruded or OTW, etched PTFE liners to improve the adhesion of the subsequent jacket at the time of the reflow process of catheter construction.
Metallic Hypotubes — Furthermore, it is feasible to use tie layer coatings together with an etched PTFE liner and to be applied to the ID of a metallic tube, like a laser-cut hypotube, to make a very low friction ID (lumen).
Other — It is possible to apply tie layer coatings to components that can be coated and require optimized bondability to top-layer applied materials.
Biocompatibility — When it comes to medical applications, only USP Class VI approved thermoplastic materials are used for tie layer coatings.
Heat Weldable — The fact that tie layer coatings easily melt and match with any jacket reflow process enables them to create a strong, heat-welded bond.
Thin Layer — The overall dimensions of the device of a user can be minimized since the thickness of the tie layer coatings could be as low as 0.0001″, or 0.0025 mm.
Bond Strength — Tie Layer improves the liner-to-jacket bond strength by at least 2.5× over non-tie-layered jacket construction.