New compounds for medical devices

Phenomenal growth in medical device sector has demanded improved materials capable of meeting the stringent standards for medical and pharmaceutical products. Market leaders producing medical devices compete with each other leading to intensified efforts towards innovation. Rising raw materials and production costs are encouraging the development of new compounds that answer the call for enhanced properties making them ideal for various medical applications. 

A PVC-free medical tubing line was launched recently by Teknor Apex Company, in tandem with  American Kuhne Inc. The PVC-free medical tubing line runs at speeds up to 830 ft/min whilst processing Teknor Apex's Medalist? medical elastomer. The high speed extrusion line ran a 0.105 in. (2.67mm) OD x 0.020 in. (0.508mm) wall tube up to 830 ft/min (253 m/min.) line speed. At 600 ft/min (183 ft/min) line speed, tight tolerances of +/- 0.0004 in. on the OD and +/- 0.0001 in. on the wall thickness were held. The extrusion system consisted of an American Kuhne ULTRA series 2.0 in. (50 mm) extruder with AKcess Level II Touchscreen System; inline spiral flow die head; Conair multi-pass vacuum tank with servo driven wheel to minimise the rubber band effect and to minimise tension within the process; servo driven nip roller puller; automatic cut and transfer coiler and a Zumbach ID/OD/WALL tube measurement system with closed-loop control of the OD and wall thickness. The compound used in this run was MD-585, an 83 Shore A compound that is part of the Medalist? MD-500 series for tubing applications.

Recent innovations in radio frequency welding, adhesive bonding, and solvent bonding enable components produced from Medalist elastomers to be used as readily as PVC in the assembly of medical devices. Medalist MD-500 compounds provide the total package of requirements for successful tubing applications - processability, ease of fabrication, and outstanding end-use performance. The compounds provide mechanical properties equal to or better than those of the flexible PVC widely used for medical tubing; at least as important, they yield tubing that looks and handles like PVC. This means similar crystal clarity, clamp resilience, resistance to kinking and necking, and an overall PVC-like 'feel'.

The Medalist programme for medical manufacturers now includes 28 standard high-purity elastomer compounds, along with a comprehensive body of test data and resources for designers and processors. Compounds are available with hardness from Shore OO 25 to Shore A 87 and include clear, translucent, and opaque formulations.

PVC- free medical tubing produced from Medalist elastomers

In support of surgical procedures
 
Another development was the launch of the industry's first fully-adjustable plastic positioning support for orthopedic trauma surgery. The Bender adjustable positioning triangle, made of Radel? polyphenylsulfone (PPSU) resin from Solvay Advanced Polymers, LLC was developed by Tri-Medics LLC. Solvay Specialty Polymers offers surgeons a simple and easy-to-use solution that is adjustable, autoclavable, and radiolucent for x-ray use.

The Bender triangle is adjustable to the human anatomy, simplifies surgical procedures, and decreases operating room time, according to Bradley Bender, Tri-Medics President and inventor of the patented device. It is a highly effective alternative to expensive and more complicated fixed positioning supports made of foam rubber and metal. "This one-of-kind device gives surgeons a broader view as well as greater control and precision," said Mr. Bender. "Radel PPSU played a major role by delivering high strength and radiotranslucence."

Radel PPSU offers high strength during intramedullary (IRacing Archives