Degradation of explanted polyurethane cardiac pacing leads and of polyurethane.
Polyurethane cardiac pacing leads explanted at autopsy and from reoperated patients were examined for degradation in the insulation. Scanning electron microscopy (SEM) analysis showed cracks on the polyurethane surface which were both parallel and perpendicular to the longitudinal axis of the lead. Surface analyses of leads were performed using Fourier-Transform Infra-red (FT-IR) spectrophotometry in the attenuated total reflectance mode. The FT-IR spectra of visibly deteriorated polyurethane from explanted lead sheaths were compared with that of unused polyurethane tubing used for such sheaths. Changes were most evident in the regions of 3000-2800, 1730 and 1368 cm-1. The observed alterations in the FT-IR spectra were consistent with a degradation mechanism involving oxidative chain cleavage in the polyurethane amorphous regions. New polyurethane tubing (Pellethane-Type 80A) was exposed to sodium hypochlorite to simulate a possible in-vivo process and generate reference material. Degradation with associated decreases in tensile strength and molecular weight was recorded. This study showed that polyurethane insulation used in pacing leads is susceptible to oxidative degradation.
Chawla
A S
AS
Bureau of Radiation and Medical Devices, Health and Welfare Canada, Ottawa, Ontario.
Blais
P
P
Hinberg
I
I
Johnson
D
D
D001672:Biocompatible Materials; D001673:Biodegradation, Environmental; D004868:Equipment Failure; D006801:Humans; D008855:Microscopy, Electron, Scanning; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D011140:Polyurethanes; D013055:Spectrophotometry, Infrared
D001672:Biocompatible Materials; D011140:Polyurethanes