D. P. Martin*, and S. Rizik
Tepha, Inc., 840 Memorial Drive, Cambridge, MA 02139, USA
Keywords: absorbable, biocompatible, implant, medical
Polyhydroxyalkanoates (PHAs) are a broad class of biomaterials that offer properties well suited for use in absorbable medical implants1. Until recently, however, the development of these products has been limited by the properties of the commercially available PHAs and their methods of manufacture. With the development of metabolic engineering approaches, PHA materials can be designed with specific properties and produced in organisms generally regarded as safe by regulatory agencies. We have investigated the use of flexible PHAs, such as poly-4-hydroxybutyrate (sold under the tradename of TephaFLEXTM biopolymer) as a material for implantable, medical devices2. TephaFLEXTM biopolymer is produced by a recombinant strain of Escherichia coli K12, which is the workhorse of the biotechnology industry.
TephaFLEXTM biopolymer can be melt extruded into mono- and multi-filament fibers with strength superior to some existing absorbable fibers. TephaFLEXTM monofilament suture fibers also have excellent handling properties. The fibers can be knitted, braided or woven into a variety of configurations for potential use as absorbable surgical meshes. The application of TephaFLEXTM biopolymer in some of these medical textile products will be presented.
A Device Master File was submitted in 2002 to the U.S. Food and Drug Administration for the manufacture of TephaFLEXTM biopolymer and we anticipate submitting regulatory filings to the FDA for initial medical products manufactured from TephaFLEXTM biopolymer by early 2005.
[1] Williams S. F., and Martin DP. Applications of PHAs in Medicine and Pharmacy. In Biopolymers, Vol. 4, Polyesters III, Applications and Commercial Products. Eds. Y. Doi and A. Steinbüchel. Wiley-VCH, Germany, 2002, pp. 91-127.
[2] Martin, D. P. and Williams, S.F., 2003. Biochem. Eng. J. 16, 97-105.
论文来源：International Symposium on Biological Polyesters ,Auguest 22-27, 2004
