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High Siloxane Content Polyurethanes
for Implantable Devices
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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 |
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| 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.
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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.
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