Solventless method for forming a coating on a medical electrical lead body
First Claim
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.
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Abstract
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.
48 Citations
24 Claims
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1. A solventless method for forming a therapeutic agent eluting coating on a medical electrical lead including a lead body comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A solventless method of forming a multi-layered coating on a medical electrical lead including a lead body comprising:
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dispensing a predetermined amount of a solventless admixture comprising an uncured silicone adhesive having a viscosity ranging from about 0.001 Pas to about 20 Pas and particles of a fluoro-opaque material onto the outer surface of the lead body at a location in close proximity to the at least one electrode while rotating the lead body around its longitudinal axis; curing the admixture to form a fluoro-opaque layer, wherein the fluoro-opaque layer comprises about 10 wt % to about 80 wt % of the fluoro-opaque material; dispensing a predetermined amount of a solventless suspension comprising up to about 20% (wt/wt) of therapeutic agent particles distributed within the uncured silicone medical adhesive having a viscosity ranging from about 0.001 Pas to about 20 Pas over the fluoro-opaque layer using an automated syringe while rotating the lead body around its longitudinal axis; and curing the suspension to form a polymer matrix layer that is free of residual solvent. - View Dependent Claims (23, 24)
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Specification