Reducing Delamination with the Ultra-Thin Thermoplastic Catheter

Tie Layer is an innovative catheter construction solution developed to minimize delamination and ultimately enhance patient safety. During construction, this ultra-thin thermoplastic layer is applied over a catheter liner. Tie Layer forms a melt-bondable surface that enhances adhesion to both the catheter jacket and the liner at the time of the reflow process. Tie Layer also improves yields and minimizes manufacturing cost.

In catheter construction, delamination is a difficult failure mode, which carries with it both cost and risk burden for device manufacturers. Typically, it is hard to detect until final testing — following completion of the catheter assembly — leading to considerable product loss. Delamination could even cause failures in the field as well as product recalls.

Zeus’ Tie Layer solution forms a stronger bond between the inner liner and the outer catheter jacket, thus increasing the catheter performance consistency and ultimately enhances patient safety. Apart from reducing inspection requirements, Tie Layer also reduces manufacturing costs and increases product yield. Tie Layer is a truly comprehensive solution in the design and manufacturing of catheters.

Multiple Options

Tie layers can be made use of in applications that require one surface to be bonded to another. Tie layers act as the interface layer to enhance the adhesion between the joined layers.

Catheter Assembly

Tie layers are a highly useful and convenient option that can be applied to improve the bonding of surfaces to the catheter or wire jackets. Tie layer options for catheter components include:

  • Tie layer-coated PTFE over the wire (OTW)
  • Tie layer-coated FEP or PTFE baseliners
  • Tie layer-coated polyimide tubing

It is also possible to use Tie Layer to improve adhesion of a coated liner to the ID of a metallic tube. As a matter of fact, it is possible to apply Tie Layer to nearly any round substrate.

Available Tie Layer Materials Include:

  • Tecoflex® 80A and 93A (Thermoplastic urethanes, or TPUs)
  • Pebax® — 25D to 72D durometers
  • Vestamid® 75D (Nylons)

Coating thicknesses could be as low as 0.0001″, or 0.0025 mm.

Applications

Catheter Construction — Tie layer coatings can be applied over bondable substrates like etched PTFE liners either OTW or extruded to enhance the adhesion of the subsequent jacket at the time of the catheter construction reflow process.

Metallic Hypotubes — Additionally, it is possible to use tie layer coatings in combination with an etched PTFE liner and to be applied to a metallic tube’s ID, such as a laser-cut hypotube, to produce a very low friction ID (lumen).

Other — Tie layer coatings can be applied to components that can be coated and require enhanced bondability to top-layer applied materials.

Key Properties

Biocompatibility — In the case of medical applications, only USP Class VI approved thermoplastic materials are used for tie layer coatings.

Heat Weldable — Since tie layer coatings easily melt and combine with any jacket reflow process, they form a strong, heat-welded bond.

Thin Layer — Since the thickness of the tie layer coatings could be as low as 0.0001″, or 0.0025 mm, the overall dimensions of a user’s device can be reduced.

Bond Strength — Tie Layer enhances liner-to-jacket bond strength by at least 2.5× when compared to non-tie-layered jacket construction.