Therapeutic agent delivery system and method for localized application of therapeutic substances to a biological lumen

摘要

The invention provides a system and method for localized application of therapeutic substances within a biological lumen and to the wall of the lumen. In various embodiments, a biodegradable tubular prosthesis comprising a plurality of pores is deployed within a biological lumen. Subsequent to, or in conjunction with, the deployment of the prosthesis, a drug-eluting balloon comprising at least one therapeutic agent is expanded within the lumen of the tubular prosthesis, thereby releasing the agent(s) from the balloon and delivering them to the prosthesis pores. The at least one therapeutic agent is then allowed to diffuse through the pores to the lumen wall.

主权项

1. A system for inserting a cylindrical tubular prosthesis in a biological lumen and for delivering an effective dose of at least one therapeutic agent to the wall of the lumen, comprising:
a cylindrical tubular prosthesis formed from a biodegradable material and comprising:
a cylindrical wall defined by a cylindrical inner surface and a cylindrical outer surface,a lumen defined by the cylindrical wall,a plurality of pores, whereby the cylindrical inner surface and the cylindrical outer surface are in fluid communication,a smooth gradient of pore diameter within each of the plurality of pores between the cylindrical inner surface and the cylindrical outer surface, the gradient of diameter comprising a smaller pore size at the cylindrical inner surface and a larger pore size at the cylindrical outer surface with a smooth gradual pore size increase moving from the cylindrical inner surface to the cylindrical outer surface,a first deformed configuration having a first diameter, wherein the plurality of pores are open and without the at least one therapeutic agent therein,a second expanded configuration having a second diameter, wherein the second diameter is larger than the first diameter, a delivery sheath having a lumen therethrough, wherein the tubular prosthesis is axially translatable in the first deformed configuration, and a distal end, wherefrom the tubular prosthesis is released and expanded to the second expanded configuration and deployed against the lumen wall, and an inflatable drug-eluting balloon capable of axial translation into the lumen of the expanded deployed tubular prosthesis, the balloon comprising a reservoir therein, the reservoir containing an effective dose of at least one therapeutic agent therewithin for release into the plurality of pores, and further comprising an inflation means, whereby inflation of the balloon delivers the effective dose of the at least one therapeutic agent from the reservoir within the balloon to the plurality of pores, whereby the at least one therapeutic agent enters the gradient of pore diameter for diffusion therethrough at a rate controlled by the gradient of pore diameter to the lumen wall.