Abstract: A drug delivery balloon is provided comprising a balloon having a surface, and a coating disposed on at least a portion of the balloon surface, the coating including an cytostatic therapeutic agent, an excipient, and a plasticizer. In accordance with the present subject matter, at least 30% of the coating transfers from the balloon surface within two minutes after inflation of the balloon. Alternatively, at least 30% of the coating transfers from the balloon surface within one minute after inflation. The coating results in an effective pharmacokinetic profile of an cytostatic therapeutic agent in a vasculature or target tissue.

Abstract: Methods and compositions for the sustained release of treatment agents to treat an occluded blood vessel and affected tissue and/or organs are disclosed. Porous or non-porous bioabsorbable glass, metal or ceramic bead, rod or fiber particles can be loaded with a treatment agent, and optionally an image-enhancing agent, and coated with a sustained-release coating for delivery to an occluded blood vessel and affected tissue and/or organs by a delivery device. Implantable medical devices manufactured with coatings including the particles or embedded within the medical device are additionally disclosed.

Abstract: A stent of variable surface area as determined by stent struts. The stent can have a variable surface area per unit length which accommodates a therapeutic agent. A patterned distribution of therapeutic agent can be provided throughout the stent. The stent can have an increased level of therapeutic agent near an end of the stent. A decreased level of therapeutic agent can be provided near an end of one embodiment of a stent. Indentations can be provided at the surface of the stent with therapeutic agent disposed therein. The stent can be cut with struts of variable thickness to provide the variable stent surface area.

Abstract: A stent of variable surface area as determined by stent struts. The stent can have a variable surface area per unit length which accommodates a therapeutic agent. A patterned distribution of therapeutic agent can be provided throughout the stent. The stent can have an increased level of therapeutic agent near an end of the stent. A decreased level of therapeutic agent can be provided near an end of one embodiment of a stent. Indentations can be provided at the surface of the stent with therapeutic agent disposed therein. The stent can be cut with struts of variable thickness to provide the variable stent surface area.

Abstract: A hybrid stent is formed which exhibits both high flexibility and high radial strength. The expandable hybrid stent for implantation in a body lumen, such as a coronary artery, consists of radially expandable cylindrical rings generally aligned on a common longitudinal axis and interconnected by one or more links. In one embodiment, a dip-coated covered stent is formed by encapsulating cylindrical rings within a polymer material. In other embodiments, at least some of the rings and links are formed of a polymer material which provides longitudinal and flexural flexibility to the stent. These polymer rings and links are alternated with metallic rings and links in various configurations to attain sufficient column strength along with the requisite flexibility in holding open the target site within the body lumen. Alternatively, a laminated, linkless hybrid stent is formed by encapsulating cylindrical rings within a polymer tube.

Abstract: The present invention provides a block copolymer for a coating on an implantable device for controlling release of drug and methods of making and using the same.

Abstract: A biocompatible plasticizer useful for forming a coating composition with a biocompatible polymer is provided. The coating composition may also include a biobeneficial polymer and/or a bioactive agent. The coating composition can form a coating on an implantable device. The implantable device can be used to treat or prevent a disorder such as atherosclerosis, thrombosis, restenosis, hemorrhage, vascular dissection or perforation, vascular aneurysm, vulnerable plaque, chronic total occlusion, claudication, anastomotic proliferation for vein and artificial grafts, bile duct obstruction, ureter obstruction, tumor obstruction, or combinations thereof.

Abstract: An intravascular stent includes an eluting sheath fabricated from a mesh for controlled release of therapeutic drugs and for delivery of the therapeutic drugs in localized drug therapy in a blood vessel. The eluting sheath is attached to at least a portion of an outside surface area of the stent structure and is fabricated from a mesh designed to neck down in response to a radially outward directed force resulting in the uniform expansion of the stent. The eluting sheath can be loaded with at least one therapeutic drug for the release thereof at a treatment site to facilitate repair of a damaged vessel. The stent has a high degree of flexibility in the longitudinal direction, yet has adequate vessel wall coverage and radial strength sufficient to hold open an artery or other body lumen.

Abstract: An intravascular stent includes an eluting sheath fabricated from a mesh for controlled release of therapeutic drugs and for delivery of the therapeutic drugs in localized drug therapy in a blood vessel. The eluting sheath is attached to at least a portion of an outside surface area of the stent structure and is fabricated from a mesh designed to neck down in response to a radially outward directed force resulting in the uniform expansion of the stent. The eluting sheath can be loaded with at least one therapeutic drug for the release thereof at a treatment site to facilitate repair of a damaged vessel. The stent has a high degree of flexibility in the longitudinal direction, yet has adequate vessel wall coverage and radial strength sufficient to hold open an artery or other body lumen.

Abstract: Compositions for forming a self-reinforcing composite biomatrix, methods of manufacture and use therefore are herein disclosed. Kits including delivery devices suitable for delivering the compositions are also disclosed. In some embodiments, the composition can include at least three components. In one embodiment, a first component can include a first functionalized polymer, a second component can include a second functionalized polymer and a third component can include silk protein or constituents thereof. In some embodiments, the composition can include at least one cell type and/or at least one growth factor. In some embodiments, the composition can include a biologic encapsulated, suspended, disposed within or loaded into a biodegradable carrier. In some embodiments, the composition(s) of the present invention can be delivered by a dual lumen injection device to a treatment area in situ, in vivo, as well as ex vivo applications.

Abstract: Methods for modifying a balloon of a catheter assembly are disclosed.

Abstract: A system for coating implantable medical devices, such as stents, and a method of coating stents using the system is also disclosed. The system includes a barrier or barriers for isolating an area of the stent on which a composition for coating a stent is applied. Two coating compositions can be applied simultaneously to a stent by separate nozzles on different sides of a barrier. Cross-contamination of the compositions is prevented by the barrier.

Abstract: A method including introducing a treatment agent at a treatment site within a mammalian host; and introducing a bioerodable gel material at the treatment site. An apparatus including a first annular member having a first lumen disposed about a length of the first annular member and a first entry port at a proximal end of the first annular member, and a second annular member coupled to the first annular member having a second lumen disposed about a length of the second annular member and a second entry port at a proximal end of the second annular member, wherein the first annular member and the second annular member are positioned to allow a combining of treatment agents introduced through each annular member at the treatment site.

Abstract: A coating for an implantable medical device is provided comprising a first layer including a first polymer and a second layer including a second polymer. The second layer is disposed over at least a portion of the first layer. The second polymer has a lower degree of hydration than the first polymer.

Abstract: An apparatus for coating implantable medical devices, such as stents, and a method of coating stents using the apparatus is also disclosed. The apparatus includes a barrier or barriers for isolating an area of the stent on which a composition for coating a stent is applied. Two coating compositions can be applied simultaneously to a stent by separate nozzles on different sides of a barrier. Cross-contamination of the compositions is prevented by the barrier.

Abstract: The present invention relates to a method of polishing an implantable medical device. The method may include positioning an implantable medical device on a support. At least a portion of a surface of the implantable medical device may include a polymer. A fluid may be contacted with at least a portion of the surface of the positioned implantable medical device. In an embodiment, the fluid may be capable of dissolving at least a portion of the polymer at or near the surface of the implantable medical device. The method may further include allowing the fluid to modify at least a portion of the surface of the positioned medical device. A majority of the contacted fluid may be removed from the surface of the implantable medical device. In certain embodiments, the modified portion of the surface may be substantially less thrombogenetic and substantially more mechanically stable than an unmodified surface.

Abstract: Methods and compositions for the sustained release of treatment agents to treat an occluded blood vessel and affected tissue and/or organs are disclosed. Porous or non-porous bioabsorbable glass, metal or ceramic bead, rod or fiber particles can be loaded with a treatment agent, and optionally an image-enhancing agent, and coated with a sustained-release coating for delivery to an occluded blood vessel and affected tissue and/or organs by a delivery device. Implantable medical devices manufactured with coatings including the particles or embedded within the medical device are additionally disclosed.

Abstract: An implantable medical device, such as a stent or graft, having asperities on a designated region of its outer surface is disclosed. The asperities can serve to improve retention of one or more layers of a coating on the device and to increase the amount of coating that can be carried by the device. The asperities can be formed by using a stream of pressurized grit to roughen the surface. The asperities can also be formed by removing material from the outer surface, for example, by chemical etching with or without a patterned mask. Alternatively, the asperities can be formed by adding material to the outer surface, for example, by welding powder particles to the outer surface or sputtering.

Abstract: A copolymer comprising a block of an elastin pentapeptide and method of making and using the copolymer are provided.

Abstract: The present invention relates to a composition of a first single enantiomer homopolymer and a separate stereocomplex formed of a second single enantiomer homopolymer and it mirror image enantiomer, wherein the first and second single enantiomer homopolymers can be the same or different.