Stent graft with releasable therapeutic agent and soluable coating
AssigneeMED Institute, Inc.
InventorsPatrick H. Ruane, Priscilla Reyes, Blayne A. Roeder, Amy M. Vibbert
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Abstract
Medical devices for implantation within a body vessel comprising a graft material and a releasable therapeutic agent are provided. The graft material preferably comprises a biocompatible polyurethane and a therapeutic agent. Preferably, the medical device is a stent graft formed by attaching a polyurethane graft material comprising an elutable taxane therapeutic agent to a radially expandable frame.
Claims20
A method of treating a biliary tumor comprising the steps of
- a. intralumenally inserting a radially expandable coated stent graft in a radially compressed configuration into a body vessel, the coated stent graft having an abluminal surface with a surface area and a luminal surface defining a drainage lumen, the coated stent graft having a graft material attached to a radially expandable support frame, and a coating comprising a poly(alkyl glycol) polymer on the abluminal surface of the graft material;
- the graft material containing a taxane therapeutic agent and a polyurethane polymer and forming at least a portion of both the luminal surface and the abluminal surface, the graft material formed from a polymer including polydimethylsiloxane and a polyurethane and further including about 5-100 micrograms of the taxane therapeutic agent per mm2 of the surface area of the abluminal surface with a weight ratio of the taxane therapeutic agent to the poly(alkylene glycol) of between about 0.10 and 3.50;
- b. translating the stent graft within the body vessel to position the stent graft within a biliary duct proximate the biliary tumor;
- and
- c. radially expanding the stent graft within the biliary duct so as to place the stent graft in contact with a portion of a wall of the biliary duct in a manner effective to deliver the taxane therapeutic agent to the wall of the biliary duct.
A coated tubular stent graft having an abluminal surface with a surface area and a luminal surface defining a drainage lumen, the coated stent graft comprising:
- a graft material attached to a radially expandable support frame to form at least a portion of both the luminal surface and the abluminal surface of the coated tubular stent graft and a coating including a glycol polymer on the portion of the graft material forming the abluminal surface, the graft material containing about 5-100 micrograms of a taxane therapeutic agent per mm2 of the surface area of the abluminal surface and a polyurethane polymer comprising a polymer including polydimethylsiloxane and a polyurethane, the stent graft having a weight ratio of the taxane therapeutic agent to the glycol of between about 0.10 and 3.50.
A method of manufacturing a stent graft, the method comprising the steps of:
- a. forming a first solution comprising a taxane therapeutic agent, a polymer and a solvent, the concentration of the taxane therapeutic agent being less than about 400 mM in the first solution and the polymer including polydimethylsiloxane and at least one polymer selected from the group consisting of:
- polyurethane and polyureaurethane;
- b. contacting the first solution with a radially expandable support frame and drying at least a portion of the first solution contacting the support frame to form a graft material attached to the support frame to form an abluminal surface, the graft material containing about 5-100 micrograms of a taxane therapeutic agent per mm2 of a surface area of the abluminal surface;
- c. applying a poly(alkyl glycol) polymer to the graft material to form a coating consisting essentially of the poly(alkylene glycol) on at least a portion of the graft material to form a coated stent graft having a weight ratio of the taxane therapeutic agent to the poly(alkyl glycol) of between about 0.10 and 3.50.
Dependencies are inferred from the claim text.