Could This New Heat Shrink Simplify Catheter Manufacturing?

Zeus claims its new FluoroPEELZ removes some major headaches when it comes to producing catheters.

Nancy Crotti

A South Carolina company is touting a new heat-shrinkable assembly aid that decreases damage to catheters during manufacturing, reducing waste and the necessity of specialized operator training.

FluoroPEELZ is a fluoropolymer heat shrink from Zeus (Orangeburg, SC) that operators can easily peel rather than cut off from the catheter shaft after the reflow heating process in which the inner layers of the catheter are combined.

Other heat shrinks may have score lines, perforations, or thinned out walls, all of which may increase the likelihood that an operator will damage the catheter assembly under the heat shrink, according to Irina Roof, Ph.D., a material scientist at Zeus.  Nicked or damaged catheters must be discarded, leading to waste, longer production times, and added cost, according to Roof.

The longer the catheter and the smaller the diameter, the greater the risk that damage will occur. The new assembly aid allows for long, continuous lengths of the heat shrink and an easier subsequent removal after the reflow is complete. The material is clear, allowing manufacturers to monitor the reflow process in position, Roof added.

The process also requires sufficient hoop strength to properly reflow and bond materials below the heat shrink, Roof explained.

FluoroPEELZ' compression strength is comparable to traditional fluoropolymer heat shrinks that have been on the market for years, so manufacturers need not vary their process much, she added.

Operator training also becomes more streamlined with the new heat shrink.  Operators can make a small cut in the end of the tube and pull it apart, allowing it to evenly peel from the catheter surface. FluoroPEELZ will benefit makers of neurologic and pediatric catheters, whose small size makes them more prone to damage, according to Roof.

"Removing the heat shrink has become very easy," she said.

Zeus is presently offering the new heat shrink in standard 3-to-18 Fr. sizes, and is in the process of developing smaller and larger ones.

Zeus worked for years to develop a peelable catheter assembly aid, but attacked the problem more intensely in the past year-and-a-half. Identifying the material proved one of the biggest challenges, as well as achieving clarity and compression strength.

"The combination of the material selection as well as processing development is what led us to a successful product," Roof said.

The product, which has Class VI approval,debuted at MD&M West in Anaheim, CA, in February. (Visit Zeus' exhibitor booth at BIOMEDevice Boston, May 6-7, 2015, or MD&M East in New York City, June 9-11, 2015.)

Roof declined to identify competitors in the heat-shrink tubing sector, and which catheter manufacturers have ordered FluoroPEELZ.

"The customers' yields have increased tremendously," she allowed. "You don't have to throw away the entire construction because of a nick."

Nancy Crotti is a contributor to Qmed and MPMN.

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