MP 2001 Speakers

 

Mike Skalsky

 

High Siloxane Content Polyurethanes for Implantable Devices

AorTech Biomaterials Pty Ltd, Unit 2/10 Rodborough Rd, Frenchs Forest, NSW 2086, Australia

Tel: +612 94515822   Fax: +612 94515388                                                    E-mail: info@aortechbio.com

Biography

Dr Michael Skalsky has a PhD in Chemical Engineering and an executive MBA from the University of NSW, Australia. He has gained extensive experience in biomaterial and device development as the Head of BioInterface Research at Telectronics. Dr Skalsky chaired the Australian Medical Engineering Association, was on the Executive of the Medical Industry Association of Australia and also acted as a member of the Australian Government Research Grants Committee. Prior to leaving to found Elastomedic Pty Ltd. (recently renamed AorTech Biomaterials), he was the Deputy Director of the Cooperative Research Centre for Cardiac Technology in Sydney.

Dr Skalsky is a member of the Australian and US Society for Biomaterials, holds several patents related to devices and has numerous publications in the field of implantable materials. His present role is Managing Director of AorTech Biomaterials, a division of AorTech International plc.

 

Abstract

The choice of elastomers for use in non-rigid implantable medical devices has been limited to silicones and polyurethanes. Silicones have demontrated long term stability but lack the mechanical strength that polyurethanes posses. Flexible polyurethanes fall short on biostability. Consequently, materials that combine the best characteristics of both offer device designers scope to meet device requirements without over-engineering to compensate for drawbacks of the individual materials.

High siloxane content polyurethanes were synthesised using conventional isocyanates (MDI), but with the usual polytetramethylene based soft segment replaced with a combination of siloxane and compatibilising macrodiol (polyhexamethylene, PHMO) in a 80/20 ratio. The chain extender can be either a conventional material (butane diol, BDO) or BDO in conjunction with another version of siloxane.  Biostability of these materials is tested using an ovine subcutaneous strained implant model, using Pellethane 2363 80A and 55 D as controls.

The family of these polyurethanes,(trade name Elast-Eon) can be made without catalysts and antioxidants. Even with close to 50% siloxane content by weight, the mechanical properties are comparable to other commercially available polyurethanes. Biostablity test results have shown that at durometers as low as 70 A, Elast-Eon materials have excellent biostablity (equivalent to Pellethane 2363 55 D), wheras Pellethane 2363 80A degrades substantially under the same test conditions.

The Elast-Eon materials can be processed by conventional thermal processing methods or alternately cast from solution. Their excellent biostablity, versatility and flexibility makes them candidates for a range of  implantable device applications.