The problem of delamination is an all-too-common issue for product engineers at catheter manufacturing companies. The term ‘delamination’ refers to the separation of material layers within the catheter.
These issues typically remain undetected until final testing, after completion of the catheter assembly, which creates significantly high scrap costs for manufacturers. The consequences of device failure in the field are serious. Patient safety is risked, and the drawn-out and expensive challenges of a product recall may follow.
A Recurring Vulnerability
Zeus, through their close relationships with key global players in catheter manufacturing, understands the urgent need for a delamination solution. A recurring vulnerability has been identified across the industry by their Global Medical Market team: namely, the separation between the jacket and the etched PTFE liner and braiding within the catheter. If this issue could be reduced, or possibly eliminated, the reliability of catheters could be transformed.
“Tie Layer” Development
The R&D team at Zeus think they have found the solution. This lies within the design of an additional material layer, to be placed between the inner etched PTFE liner and the outer jacket material of the catheter. This layer would provide the vital adhesion needed to stop delamination, ideally without increasing the finished catheter’s outer diameter.
Zeus engineers attained a design to improve catheter reliability after intensive trialing. An ultra-thin thermoplastic coating was created, to be applied to the PTFE liner before catheter construction. Tie Layer is designed specifically to adhere to the freshly etched PTFE liner surface, and is conventionally created from the same materials as the catheter jacket, which generates a like-for-like bond between jacket and liner.
Testing of these catheters demonstrates that they have a 2.5 x stronger bond than those catheters without a Tie Layer. In addition, any impact to the overall catheter profile is minimal, with coating dimensions as thin as 0.0025 mm (0.0001″). Significant reduction in delamination is thus proven by this innovative step.
How Tie Layer Transforms the Production of Catheters
1. Increased safety of patients – a significant risk to patients is posed through product failure thanks to liner/jacket delamination in the catheter
2. Improved profitability – reduction of expensive product recalls for manufacturers, as well as scrap rates, and inspection costs. Increased throughput and product yield relieves pressure on the bottom line.
3. Generation of new design possibilities – once the issue of delamination under control, design engineers and R&D teams can focus on innovating when developing their next generation catheters.
4. Ameliorated performance – R&D engineers with access to various Tie Layer materials and fluctuating durometers can customize elasticity or stiffness into their next design. This, in real terms, translates to increased trackability, deliverability and overall performance.
Zeus’ commitment and contribution to the industry through medical device innovation is demonstrated in the creation of the Tie Layer. This product’s development and success was made possible through Zeus’ close working relationships with customers in the catheter manufacturing industry.
Zeus was able to isolate and pre-empt the issue and generate an appropriate and effective solution, thanks to their critical understanding of device design issues- a solution which is now on course to revolutionize both safety and prosperity for catheter manufacturers.
About Zeus Inc.
Zeus were among the first to work in the arena of minimally invasive techniques for revolutionary procedures such as neuromodulation. Their PEEK drawn fiber offers a non-metallic replacement for stainless steel. And when a major aircraft manufacturer needed an immediate design change on a harness assembly, Zeus delivered in record time.
Zeus has vast experience in medicine, aerospace, energy exploration, automotive, fiber optics and more allowing you to leap past “can’t” and into “how”.
What makes them different is that they think differently. Even though they’re the world’s leading expert in polymer tubing, they’re much more than a polymer tubing company. Zeus solves problems and anticipates innovation. Zeus are in the business of changing lives.
History of Zeus Inc
Frank P. Tourville, Sr. worked in the polymer extrusion industry for ten years before creating Zeus from a desire to “do it better.” While Zeus quickly established itself as a world leader providing high-performance polymer extrusions and solutions, their rapid, sustained growth is rooted in a commitment to improving industries and lives.
Zeus is Everywhere You Are
Zeus touches just about every major industry in the world. Their products make everyday life better, faster, safer. You’ll find Zeus technology in your backyard grill and automobile. You’ll find them in the aircraft taking you where you need to go and the hand of the surgeon saving your life. Zeus' research facilities are surpassed only by the enthusiasm and commitment of our people.
Why Choose Zeus As An Innovation Partner?
When your product and reputation are on the line, you want the best. No other company in the world delivers the consistency, dependability and unrivaled innovation of Zeus.
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