High-precision equipment can coextrude in up to four layers.
New microextrusion technology is allowing a tubing manufacturer to produce microsized thermoplastic tubing for neurovascular and surgical applications. Glass and fluoropolymers have typically been used for such uses because of their ability to consistently hold tolerances, but Natvar, a Tekni-Plex company, has recently made strides that allow it to microextrude the more-affordable thermoplastic, the company reports.
Natvar recently installed "several new high-precision extruders enclosed in their own Class 8 cleanroom environment," Bob Donohue, general manager, Natvar, told Qmed. "The extrusion line, cleanroom, and downstream equipment are all designed to provide the highest possible quality product for microextrusions."
Natvar is now using a variety of thermoplastic (PVC, urethanes, TPEs) materials at CPK values above 2.0 to produce monolayer, coextruded, and multi-lumen tubing or profiles in wall thicknesses ranging from 0.003 to 0.005 in. and coextruding up to four layers.
When comparing thermoplastics with fluoropolymers and glass for microextruded tubing, "cost is reduced by 15 to 40 percent depending on application and materials used," Donohue reported. "From a performance standpoint, the product tolerance is key and the main driver. Some product lines are driven exclusively by ID performance to deliver medications at a constant flow rate or restrict medications to a certain flow rate."
Natvar's new manufacturing line can also run fluoropolymers if requested. "The medical device manufacturer may opt to stay with fluoropolymer tubing for a variety of reasons including properties and to avoid validating a different material," Donohue said. "Natvar's new microextrusion tubing line can also run fluoropolymers, but offer tighter tolerances then they are currently getting. It is much easier to change a supplier than it is to change supplier and materials."
The new equipment will also help Natvar meet the industry's ongoing need for smaller and smaller tubing. "Medical devices continue to decrease in size," he said. "To help address those needs, Natvar continuously commits its resources to innovation. One of the ways we do that is by partnering with original equipment manufacturers to improve both extrusion innovation and help facilitate speed-to-market for new medical devices."
Donohue reports that Natvar has "already have produced microextrusion tubing within a short development lead time. We have been successful in getting products right in the first pass, eliminating the need to create multiple generations. This capability is an added bonus for those with tight speed-to-market objectives."
Target applications for the microextrusion tubing line include IV cannulas, pediatric devices, infant microcatheters, guidewires, catheter leads and any others where diameter and tight tolerances are necessary to achieve product objectives.
Visit Natvar at Booth #1433 at Medical Design & Manufacturing East in New York June 13-15.