Porous composites with high-aspect ratio crystals
AssigneeW.L. Gore & Associates, Inc.
InventorsRobert L. Cleek, Edward H. Cully, Paul D. Drumheller, Mei Li, Peter D. Traylor
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Abstract
The present disclosure is directed toward composite materials comprising high aspect ratio habits of drug crystals which can be partially or fully extending into a substrate, and additionally, can be projecting from a substrate at an angle of about 20° to about 90°. The present disclosure is directed toward medical devices, such as medical balloons, comprising said composite and methods of using and making the same. The described composite can be used for the local treatment of vascular disease. The present disclosure is also directed toward paclitaxel crystals with a hollow acicular habit.
Claims57
A composite comprising a plurality of high aspect ratio paclitaxel crystals projecting from a porous substrate at an angle of at least 20 to 90 degrees relative to the substrate and extending at least partially into said porous substrate.
A method of preparing a composite comprising a porous substrate and a drug crystal of high aspect ratio habit, such that the crystals are at least partially extending into the substrate and are projected from substrate at an angle of about 20 to 90 degrees with respect to the substrate and comprising the steps of
- preparing a solution of drug in the organic solvent, wherein the organic solvent is capable of wetting the substrate;
- applying the solution to the porous substrate;
- and
- causing the solvent to evaporate to form the drug crystal.
A method of treating a disease locally comprising the steps of
- radially expanding medical device from a first diameter to a second diameter,
- wherein the medical device comprises a substrate and the substrate contacts a tissue upon expansion and
- wherein the substrate comprises a polymeric substrate comprising a plurality of high aspect ratio paclitaxel crystals that at least partially project from the substrate at an angle of at least 20 to 90 degrees relative to the substrate and at least partially extend into the substrate.
A drug crystal comprising paclitaxel having a hollow crystal habit.
A composite material comprising
- a substrate comprising a porous microstructure and
- an amount of crystalline paclitaxel comprising hollow crystal habits associated with the substrate.
A method of making a drug delivery device having a substrate comprising
- applying a solution comprising paclitaxel and an organic solvent to the substrate;
- allowing paclitaxel to crystallize through evaporation of the solvent,
- wherein the substrate comprises a polymer having a node and fibril microstructure and wherein the organic solvent is capable of wetting the node and fibril microstructure.
A method of making a drug delivery device having a substrate comprising the steps of
- applying a solution comprising paclitaxel to a substrate;
- causing the paclitaxel to crystallize;
- and
- exposing the paclitaxel to a vapor phase solvent to cause the paclitaxel to form acicular crystal habits that project from the surface at an angle of between 20 to 90 degrees.
The method of claim 45, wherein the vapor phase solvent comprises at least one of acetonitrile, methanol, and ethanol.
A medical device comprising
- an outer surface having a porous substrate,
- a plurality of high aspect ratio paclitaxel crystals extending at least partially into said porous substrate,
- wherein the medical device comprises a first diameter and a second, diameter, wherein the substrate is adapted to contact a tissue upon expansion to the second diameter.
The medical device of 52, wherein the porous substrate comprises expanded polytetrafluoroethylene.
A method of preparing at least one drug crystal of high aspect ratio habit comprising the steps of
- preparing a solution of drug in the organic solvent, wherein the organic solvent is capable of wetting the substrate;
- applying the solution to the porous substrate;
- causing the solvent to evaporate to form the at least one drug crystal;
- and
- removing the at least one drug crystal from the substrate.
Dependencies are inferred from the claim text.