By: Roger Renstrom
April 2, 2013
ANAHEIM, CALIF. -- Polycarbonate and PC blends from Bayer MaterialScience LLC are making inroads in the medical arena.
The materials are helping medical-device developers Cannuflow Inc., Cardiac Science Corp., Infusion Innovations Inc. and others create new and upgraded products, said executives of the firms.
BMS supplies its Makrolon Rx1452 PC for Cannuflow's EntreVu EX cannula, used in hip and shoulder arthroscopic surgeries. The EntreVu EX device features the firm's patent-pending anti-extravasation Extravastat technology, which acts as a channel to wick away irrigation fluid that could leak from the joint into muscle tissue during surgery to cause painful interstitial swelling and post-surgical complications.
The PC's clarity allows a surgeon to see sutures and surgical knots during surgery, according to BMS and San Jose, Calif.-based Cannuflow.
Cannuflow founder and CEO Ted Kucklick, who designed EntreVu EX, said in a news release that the PC's moldability allows for low-profile wall sections and long core pulls, facilitating the creation of a two-layer cannula with no increase of outer diameter, vs. generic cannulas.
Being able to use an existing moldable and biocompatible material was helpful in creating the new cannula surgical access portal, BMS' Bruce Fine said in an interview at Medical Design & Manufacturing West.
Fine, who is PC market segment leader for medical and consumer products, said BMS also has developed a clear high-flow medical Makrolon PC, called Rx2440, that can offer a faster recovery time in color shift. Select North American customers are involved in its final development stages, Fine said.
He said the material allows designers to take advantage of PC's high stiffness to design thinner walls and helps molders increase productivity.
The PC can be sterilized with high-energy radiation — including gamma or electron beam — or ethylene oxide, and the material will return quickly to its original color, Fine said.
The Rx2440 PC is suitable for applications that meet ISO 10993-1 and U.S. Pharmacopeial Class VI biocompatibility requirements.
.Another medical-grade Makrolon PC — tagged Rx1805 — makes up two of the three components of I3's Q-Flo-brand closed male luer lock mechanism.
Infusion Innovations Inc.'s medication-delivery device features a closed, no-drop, valved connector that prevents drips and spills, protecting administering medical personnel from exposure to cytotoxic drugs. The Food and Drug Adminstration gave marketing clearance to Q-Flow in July.
The Makrolon PC offers a level of chemical resistance required for use in cytotoxic and nuclear medicine, I3 President Babak Nemati said in a news release. That, and the material's strength, clarity, lipid resistance, biocompatibility and gamma stability were factors in its selection. The connector can be imbedded into the barrel of a 3-cubic-centimeter syringe.
Q-Flo was developed over a nine-month period, said Brody Hammond, a Bayer technical marketing specialist in Oceanside, Calif. The material needed to be gamma stable, compliant with ISO 10993-1 and suitable for USP Class VI tests for up to 30 days' contact with human tissue.
Hospital safety product developer I3 is based in La Jolla, Calif.
A BMS PC/ABS blend replaced a PC blend from another supplier for injection molded components of a next-generation Powerheart AED from Cardiac Science, according to Bayer. BMS said Nashotah, Wis.-based Dickten Masch Plastics LLC molds the battery case and electronics housing for Cardiac's G5 Powerheart automated external defibrillator, using Bayblend flame-retardant, non-reinforced FR3010 PC/ABS.
The AED's updated technology and design was approved by European regulators in 2011; Cardiac is still waiting on authorization from the FDA.
AEDs, used by emergency and military service personnel, can face rugged conditions requiring the devices to be durable without sacrificing life-saving features, said Mike Fry, general manager of Cardiac's resuscitation business.
In January, Cardiac deployed 440 of its Powerheart G3 AEDs to all Chicago-area Metra commuter trains and facilities.
Bayer's Newark, Ohio, design center used its Leda compounding technology to color-match Cardiac's corporate color scheme of orange and gray. Cardiac Science of Waukesha, Wis., is a brand company of Opto Circuits (India) Ltd. of Bengaluru, India.
For wound management, the Bayer Films business has new cross-linked aliphatic non-yellowing polyurethane foam based on its Baymedix FP reactive foam technology. The foam can be coated with a skin-friendly two-component hydrophilic strength-adjustable adhesive of Baymedix A materials.
"The highly engineered breathable film of [thermoplastic] PU is water-repellant on the outside, and water vapor can escape for faster healing," said Chris Cooper, Bayer business development manager for specialty functional films in in South Deerfield, Mass.
BMS of Pittsburgh exhibited at MD&M, held Feb. 11-14 in Anaheim. The firm is part of Bayer AG of Leverkusen, Germany.