Medical device comprising polyhydroxyalkanoate having pyrogen removed using oxidizing agent

摘要

Polyhydroxyalkanoates (PHAs) from which pyrogen has been removed are provided. PHAs which have been chemically modified to enhance physical and/or chemical properties, for targeting or to modify biodegradability or clearance by the reticuloendothelial system (RES), are described. Methods for depyrogenating PHA polymers prepared by bacterial fermentation processes are also provided, wherein pyrogens are removed from the polymers without adversely impacting the polymers' inherent chemical structures and physical properties. PHAs with advantageous processing characteristics, including low melting points and/or solubility in non-toxic solvents, are also described. The PHAs are suitable for use in in vivo applications such as in tissue coatings, stents, sutures, tubing, bone, other prostheses, bone or tissue cements, tissue regeneration devices, wound dressings, drug delivery, and for diagnostic and prophylactic uses.

主权项

1. A biocompatible medical device comprising
a polyhydroxyalkanoate polymer which is prepared using a process which introduces a pyrogen into the polyhydroxyalkanoate, wherein the pyrogen is removed from the polyhydroxyalkanoate using an oxidizing agent under conditions effective to produce a pyrogen level of less than 20 endotoxin units (EU) per device.