Avant Medical, a leading medical technology manufacturer based in San Diego, California, is currently developing the latest generation of its Pulse Injection® technology for needleless injection of medications. The "Gen 3" device is capable of delivering up to 30 doses from a single medication reservoir. To make its product, Avant Medical utilizes both Makrolon® Rx2530 polycarbonate and technical expertise from Bayer MaterialScience LLC.
The patented products from Avant Medical are intended for people who must frequently self-administer medications, or for use in a clinical setting by healthcare professionals. The Pulse Injection® system is based on vacuum stabilization and two-stage delivery to ensure reliable and convenient injections. Each drug dose is delivered through a cassette with a nozzle component molded from Makrolon® Rx2530. The injector provides a fluid pathway for the drug, while also generating a pulse that punctures the skin.
Makrolon® from Bayer MaterialScience is finding increased use in medical components made of plastic. Like Avant Medical, the Swiss company Alcon Grieshaber AG, for example, uses Makrolon® Rx2530 to make its micro forceps and scissors for opthalmic surgery. This application further incorporates the grade 2458. Markus Krieter, medical device specialist in the Polycarbonates Business Unit of Bayer MaterialScience, further cites the example of the recently introduced portable mini-injection pumps made by RoweMed AG: "Makrolon® Rx 1805, which RoweMed has used to good effect in the past, was ideally suited to the complex requirements profile of the RoweMiniPump. Our polycarbonate offers the high transparency, impact strength, drug resistance and good sterilizability required for this application."
Makrolon® Rx2530 is used for medical device applications requiring minimum color change after exposure to sterilizing doses of gamma radiation. The product also meets the requirements of the FDA-modified ISO 10993, "Biological Evaluation of Medical Devices" for 30-day indirect blood contact applications. These advantages are supported by the dimensional stability and ease of processing of the Bayer MaterialScience polycarbonates. All these factors ultimately contributed to Avant Medical's selection of Makrolon® Rx2530 for the Gen 3 device. The nozzle of the needleless injector withstands up to 45 impacts, thereby meeting the 50 percent design safety margin required by international standards. According to John Slate, Avant Medical Vice President of Operations, it was not only the material itself that was so important. "The technical support at Bayer MaterialScience helped us, through design optimization, to achieve the required strength of the nozzle. The specialists at Bayer MaterialScience were a great resource for us to call on. They know so much about their materials and are willing to spend the time and effort to ensure we have success with our end product."