Abstract: Drug delivery balloons have densely packed crystals of small particle size of the drug thereon. An amorphous drug coating is applied to a balloon surface and annealed to provide the crystals. The balloon surface is nucleated to induce formation of drug crystals in the annealing step to provide the crystals in high density with small size.

Abstract: A medical device having a polymer-free outer surface layer comprising a crystalline drug selected from the group consisting of everolimus, tacrolimus, sirolimus, zotarolimus, biolimus, and rapamycin. The device may be produced by a method comprising the steps of providing a medical device; applying a solution of the drug to said portion of the outer surface to form a coating of amorphous drug; and vapor annealing the drug with a solvent vapor to form crystalline drug; wherein a seed layer of a crystalline form of said drug having a maximum particle size of about 10 ?m or less is applied to at least said portion of the outer surface of the device before or after applying the drug solution, but before vapor annealing the amorphous coating.

Abstract: According to an aspect of the present invention, medical devices are provided which include a metallic substrate and a polymeric region disposed over and in contact with the metallic substrate. The polymeric region includes (a) a fluorine-containing polymer that contains at least one type of fluorine-containing monomer selected from a vinylidene fluoride monomer, a hexafluoropropylene monomer, and a combination thereof, and (b) an adhesion promoting copolymer that contains (i) at least one type of first monomer that covalently or non-covalently bonds with the metallic substrate and (ii) at least one type of second monomer selected from acrylate monomers, methacrylate monomers, fluorine-containing monomers, and combinations thereof.

Abstract: A medical device having a polymer-free outer surface layer comprising a crystalline drug selected from the group consisting of everolimus, tacrolimus, sirolimus, zotarolimus, biolimus, and rapamycin. The device may be produced by a method comprising the steps of providing a medical device; applying a solution of the drug to said portion of the outer surface to form a coating of amorphous drug; and vapor annealing the drug with a solvent vapor to form crystalline drug; wherein a seed layer of a crystalline form of said drug having a maximum particle size of about 10 ?m or less is applied to at least said portion of the outer surface of the device before or after applying the drug solution, but before vapor annealing the amorphous coating.

Abstract: According to an aspect of the present invention, surgical meshes are provided which release one or more antimicrobial agents in an amount sufficient to reduce the risk of microbial infection upon implantation of the mesh. Other aspects of the invention pertain to methods of making and using such surgical meshes.

Abstract: Drug delivery balloons are configured with a carrier film of biodegradable polymer. The carrier film includes a drug or has a drug carried thereon. The balloons utilize a film layering system that is designed to separate the carrier film substantially intact from the balloon when expanded, so that the carrier film and the drug are left in place at the tissue site.

Abstract: An implantable metallic medical device having a dual-layered coating with a primer layer having functional groups capable of forming an organo-metallic complex with iron species and a second biocompatible polymer layer. The primer layer is baked onto the metallic medical device functioning as a tie layer between the surface of the medical device and a second biocompatible polymer layer disposed on the primer layer. Baking improves tie layer adhesion and in some cases provides an organo-metallic complex with the metal substrate. The second biocompatible polymer may can a therapeutic agent.

Abstract: In embodiments, a stent comprises a biodegradable polymer functionalized with an adhesion-enhancing amino acid.

Abstract: A renal denervation apparatus includes a treatment element dimensioned for deployment on or within a renal artery of a patient. The treatment element comprises a predefined pattern arranged to complete at least one revolution of the treatment element. The apparatus includes a treatment source. The treatment source and treatment element are configured to cooperatively facilitate communication of an agent from the treatment source to the pattern arrangement of the treatment element. The treatment element is configured to deliver denervation therapy using the agent via the pattern arrangement to one or more regions of the renal artery adjacent the pattern arrangement, such that at least one complete revolution of the renal artery is subjected to the denervation therapy.

Abstract: Catheter devices for delivering therapeutic agent and methods of making the same. A method comprises applying, when the balloon is unexpanded and folded, a first coating to a first surface area of the balloon that is substantially exposed when the balloon is unexpanded and folded, the first coating being a coating to which the therapeutic agent coating material is substantially non-adherent; applying a therapeutic agent coating material to the balloon such that the therapeutic agent coating material adheres to a second surface area not coated with the first coating. Upon completion of the coating method, the therapeutic agent coating is substantially disposed within one or more folds of the balloon. A catheter device comprises therapeutic agent coating that is substantially covered when the balloon is unexpanded and folded. Expanding the balloon opens the one or more folds and substantially exposes the therapeutic agent.

Abstract: Medical devices comprising a balloon and a therapeutic agent disposed over the balloon. In one embodiment, an expandable sheath covers the balloon, and the expandable sheath is coated with the therapeutic agent. As the balloon is inflated, the sheath expands and causes the coating of therapeutic agent to break apart. In another embodiment, the balloon has a balloon wall comprising an outermost layer and one or more inner layers. The outermost layer is less compliant than the inner layer(s) such that cracks will form in the outermost layer as the balloon is inflated. The coating of therapeutic agent breaks apart when the relatively less compliant outermost layer cracks with the inflation of the balloon. Also disclosed are methods for making a medical device having a balloon.

Abstract: Drug delivery balloons have densely packed crystals of small particle size of the drug thereon. An amorphous drug coating is applied to a balloon surface and annealed to provide the crystals. The balloon surface is nucleated to induce formation of drug crystals in the annealing step to provide the crystals in high density with small size.

Abstract: When making a medical device having a drug coating thereon, the drug having a plurality of characteristic morphological forms, the manufacturing process is controlled to produce a predetermined ratio of said morphological forms on the device. The process has application to drug coated balloons.

Abstract: According to an aspect of the present invention, medical devices are provided which include a metallic substrate and a polymeric region disposed over and in contact with the metallic substrate. The polymeric region includes (a) a fluorine-containing polymer that contains at least one type of fluorine-containing monomer selected from a vinylidene fluoride monomer, a hexafluoropropylene monomer, and a combination thereof, and (b) an adhesion promoting copolymer that contains (i) at least one type of first monomer that covalently or non-covalently bonds with the metallic substrate and (ii) at least one type of second monomer selected from acrylate monomers, methacrylate monomers, fluorine-containing monomers, and combinations thereof.

Abstract: Disclosed herein are medical devices, such as intravascular stents, for delivering a therapeutic agent to the body tissue of a patient, and a method for making such medical devices. More particularly, the medical devices have a coating that includes a polymer that adheres to the surface of the medical device so that the coating is able to resist damage during loading, deployment and implantation.

Abstract: An ultraviolet curable lubricious coating including at least one lubricious polymer and at least one oxygen-insensitive crosslinkable polymer, methods of making and using the same, and articles coated therewith.

Abstract: Methods and devices for triggering drug release from the outer expandable portion of a balloon catheter are provided. Drug is released from a drug coated balloon catheter via a triggering condition. The triggering condition can be a change in solubility or volume or hydrolysis.

Abstract: Disclosed are coatings for medical devices. The medical device can have a surface. The coatings can have a first and a second layer. The first layer can be disposed on at least a portion of the surface of the medical device, and the first layer can comprise a first copolymer. The first copolymer can have a first polymeric unit that can adhere to the surface of the medical device and a second polymeric unit that can adhere to the second layer. The second layer can be disposed on at least a portion of the first layer, and the second layer can comprise a second copolymer. The second copolymer can comprise a third polymeric unit that can adhere to the first layer and a second polymeric unit that can provide the surface properties of the coating. Methods of applying coatings are also disclosed.

Abstract: An ultraviolet curable lubricious coating including at least one lubricious polymer and at least one oxygen-insensitive crosslinkable polymer, methods of making and using the same, and articles coated therewith.

Abstract: According to an aspect of the invention, implantable or insertable medical devices are provided, which contain one or more composite regions. These composite regions, in turn, contain (a) a polymeric component comprising a vinyl aromatic polymer and (b) a ceramic component comprising a metal or semi-metal oxide.