Comprehensive Extrusion Technologies
for Medical Catheters and Devices

Dayville, CT, USA – (June 1, 2009) – Putnam Plastics, a PolyMedex Discovery Group and pioneer in the medical polymer tubing field, announces the development of an advanced technology for producing thin walled, large diameter, low durometer urethane extrusions. These extrusions provide medical device companies, particularly gastrointestinal device companies, with increased design freedom and production capabilities and clinicians with more sophisticated tools with which to improve the quality of care for their patients.

With the continuing evolution of less invasive surgical techniques, clinicians are pushing device engineers to fit more and more technology through a working channel of limited size. New techniques such as NOTES (Natural Orifice Transluminal Endoscopic Surgery) and SPA (Single Port Access) are driving device designs consisting of fewer and larger access points, with the ever present goal to maximize the working space within. These advanced techniques also require considerable articulation of the device within the body with minimal operating forces. For the device engineer, this results in the need to utilize extrusions for the outer body of the device that are larger in diameter, have thinner walls, are highly flexible, and durable.

Thermoplastic urethane is a prime choice for such demanding applications. The extrusion technology required to extrude such materials is critical. "As diameter increases and wall thickness and durometer decreases, the extrusion process becomes increasingly unstable," explained Byron Flagg, Product Manager at PolyMedex Discovery Group. "This instability, which results in larger tolerances and lower yield rates, has forced device engineers to compromise their designs accordingly. Even after fabrication, such extrusions are extremely difficult to handle without contamination or damage, resulting in quality non-conformances, higher unit price, and overall lower value for the customer."

After extensive development, Putnam has implemented a proprietary combination of custom equipment and advanced processing conditions to address all of the historical challenges to the fabrication of this type of tubing. Improved process stability results in a larger design envelope for device engineers and improved material handling techniques reduce costs by increasing yields and product quality. Take for example any given 80A durometer urethane extrusion with a diameter greater than 0.5" (12.7mm). If the minimum feasible wall thickness had previously been 0.015" (0.38mm), it has now been reduced to 0.003" (0.08mm). If the OD tolerance had previously been +/-0.010" (0.25mm), it has now been reduced to +/- 0.002" (0.05mm). These tangible improvements reduce tolerance stack-up and allow more efficient device design. After fabrication, advanced handling techniques allow the finished components to move on to the next stage of manufacture free of defects or contamination.

This new capability is widely applicable across a broad range of custom extrusion designs with the greatest impact in OD’s greater than 0.500" and wall thicknesses of less than 0.015" in urethane durometers lower than 90A. As with all of Putnam’s custom fabrication technologies, this new capability can be applied cross functionally and integrated into designs that include features such as coextrusion, multi-lumen, wire reinforcement, etc. The end result is a wider envelope of possibility for device design engineers to meet the functional needs of clinicians without compromise.

For more information, please call (860) 774-1559 or visit the Putnam website at www.putnamplastics.com.

Putnam Plastics provide comprehensive extrusion technologies for medical catheters and minimally invasive devices. Technologies include thermoplastic and fluoropolymers extrusions, polyimide tubing, printing, tipping and machining tubes. Putnam offers development through validated manufacturing services. For more information, please visit www.putnamplastics.com.