Solventless method for forming a coating on a medical electrical lead body

摘要

A solventless method for forming a coating on a medical electrical lead is described. The method includes combining particles of a therapeutic agent with a polymeric material in a flowable form in the absence of a solvent to form a uniform suspension. A predetermined amount of the suspension is dispensed onto a portion of the lead and is then cured to form the therapeutic agent eluting layer. Additional layers such as a primer layer, fluoro-opaque layer and/or a topcoat layer can be formed using the solventless method. Employing a solventless method may avoid contraction of the layer being formed due to solvent evaporation during the curing process, and may facilitate greater control over the thickness of the therapeutic agent eluting coating.

主权项

1. A solventless method for forming a therapeutic agent eluting coating on a medical electrical lead including a lead body comprising:
dispensing a predetermined amount of a solventless suspension onto an outer surface of the lead body in close proximity to at least one electrode located on the lead body using an automated syringe while rotating the lead body around its longitudinal axis, the suspension comprising up to about 20 wt % particles of at least one therapeutic agent dispersed within an uncured silicone medical adhesive having a viscosity ranging from about 0.001 Pas to about 20 Pas; and moisture curing the suspension to form a polymer matrix layer that is free of residual solvent.