Implantable apparatus composed of a biomedical devices encapsulated with crosslinked tpu

Abstract

A method for producing increased resistance to biodegradability is provided for biomedical devices subject to in vivo implantation. Among the steps required to produce such resistance are the application of a thermoplastic polyurethane coating to the device to provide a coating, and the subsequent crosslinking of the thermoplastic polyurethane coating through the application of radiation of a sufficient intensity and duration to convert said thermoplastic polyurethane coating to a thermoset coating possessing the attribute of increased biostability.

1 . An implantable medical pacemaker or defibrillator device comprising:
 a pacemaker or defibrillator; and   an electrically conductive lead attached to the pacemaker or defibrillator; and   an encapsulation comprising a crosslinked thermoplastic polyurethane extrusion surrounding and encapsulating at least a portion of the lead, pacemaker or defibrillator from contact with tissue, blood and bodily fluids;   wherein the encapsulation provides additional protection to the device when implanted against the degrading effects of long term exposure to animal tissues and fluids as compared to an encapsulation free of crosslinked thermoplastic polyurethane.   
     
     
         2 . An implantable electrically conductive pacemaker lead comprising
 an electrically conductive pacemaker lead and   an encapsulation comprising a crosslinked thermoplastic polyurethane extrusion surrounding and encapsulating at least a portion of the lead from contact with tissue, blood and bodily fluids,   wherein the encapsulation provides additional protection to the lead when implanted against the degrading effects of long term exposure to animal tissues and fluids as compared to an encapsulation free of crosslinked thermoplastic polyurethane.