Abstract: An implantable or insertable medical device is provided which includes as components: (a) a substrate component comprising a depression that is at least partially filled with a therapeutic agent-containing material that comprises a first therapeutic agent, and (b) a pre-formed filter insert disposed in the depression such that it regulates transport of chemical species between the depression and the exterior of the device upon implantation or insertion of the device in vivo.

Abstract: According to an aspect of the present invention a method is provided which a porous medical article is contacted with a solution that contains a therapeutic agent and a solvent in order to load the pores of the medical article, after which the solvent is sublimated.

Abstract: According to an aspect of the present invention, medical devices are provided which comprise a substrate, a porous carbon layer disposed on at least a portion of the substrate surface, and a polymeric layer disposed on at least a portion of the porous carbon layer.

Abstract: The present invention is directed to methods and systems for aligning and coating a medical device during a single coating cycle. A first section of an applicator may apply a contact force to surfaces of the medical device. The contact force may align and remove surface irregularities from the medical device prior to coating the medical device with coating. The coating may be resident on a second section of the applicator.

Abstract: Provided is a coated medical device (e.g., a stent) comprising one or more surfaces having dispersed thereon a plurality of microparticles comprising an active pharmaceutical ingredient (API) and a polymer. Specifically, the microparticles are disposed on a device surface in a microparticulate phase coating, i.e., as discrete microparticles in the absence of a continuous phase coating. The medical device effectively adheres one or more APIs to its surface, and allows controlled release of the APIs from the device surface to a desired treatment area by using a minimal amount of polymer. The medical device is suitable for insertion or implantation into a subject, preferably a human. Also provided are methods for preparing and using the coated medical device.

Abstract: The invention relates generally to an implantable medical device for delivering a therapeutic agent to the body tissue of a patient, and a method for making such a medical device. In particular, the invention pertains to an implantable stent, such as an intravascular stent, having a coating comprising an inorganic or ceramic oxide, metal or inert carbon and a plurality of reservoirs in such material that contain a therapeutic agent.

Abstract: The present invention is directed to methods, processes, and systems for delivering therapeutic agent to a medical device. Under some methods, processes, and systems of the invention, particles including a magnetic material and a therapeutic agent may be directed towards a medical device via magnetic attraction. In another embodiment particles including a magnetic material may force a therapeutic agent/solvent solution into porous matrix by using a magnetic attraction. In still another embodiment, a medical device having at least a portion thereof including a magnetic material is used to attract and adhere particles comprising magnetic material and therapeutic agent to a target surface of the medical device, wherein the particles are fused to the target surface.

Abstract: The present invention is generally directed to implantable medical devices for delivering therapeutic agents to the body tissue of a patient and methods for making such medical devices. In particular, the present invention is directed to implantable medical devices, such as intravascular stents, having a surface that includes a plurality of cavities and a plurality of pores and a composition disposed in the pores and/or cavities, as well as, implantable medical devices, such as intravascular stents, having a surface that has a coating composition disposed on the surface, wherein the coating composition includes a plurality of cavities and a plurality of pores and another coating composition disposed in the pores and/or cavities.

Abstract: A method and device for coating a medical device, such as a stent, including rolling the stent against a ribbon or gravure roll impregnated with coating material. The ribbon and gravure roll may include a recessed pattern matching a strut pattern of the stent. The stent may also be rolled against a plate or cylinder while coating material is forced onto the stent through a pattern of holes or openings in the plate or cylinder matching a strut pattern of the stent.

Abstract: The present invention relates to a coating assembly and methods that employ the coating assembly to control the thickness of therapeutic or other coatings delivered to a medical device during a coating process. In one embodiment the coating assembly may include a coating plate having a coating transfer surface and a shoulder having a first height, a mandrel moveable over the coating transfer surface, and a coating dispenser positioned in fluid communication with the coating transfer surface. The invention also includes a method of coating a medical device. This method may include placing a medical device on a mandrel, dispensing coating onto a coating transfer surface of a coating plate, moving the mandrel and the medical device over the coating transfer surface of the coating plate so that coating resident on the coating transfer surface transfers to an exposed surface of the medical device, and removing the medical device from the mandrel.

Abstract: The present invention generally relates to the conditioning of coated medical devices such as stents. More specifically, the present invention relates to methods for positioning a medical device within an elution media for a predetermined time period to eliminate a burst release from the coating. Under methods and processes of the invention, a medical device target surface may be identified and coated with therapeutic. The coated surface of the medical device may then be positioned within an elution media for a predetermined period of time to release a predetermined amount of coating.

Abstract: The present invention is directed to methods, processes, and systems for selectively driving therapeutic into at least a portion of a porous matrix of a medical implant. Under methods and processes of the invention, a medical implant may be provided having at least a portion thereof comprising a porous matrix. An injector in fluid communication with a fluid source deliver therapeutic within the porous matrix. The porous matrix may be configured to control the elution rate.

Abstract: An implantable stent comprising a first strut having an abluminal surface, and subluminal surface, and at least one side surface; a first depression formed in the abluminal surface; and a first support element at least partially disposed in the first depression; wherein at least a portion of the first support element extends beyond the abluminal surface of the first strut.

Abstract: Endoprostheses (e.g., stents) containing adjustable surfaces are disclosed.

Abstract: A system and method for the electrostatic spray application of a coating material onto a medical device. The coating material is electrically charged and an atomizer is used to atomize the coating material, creating electrically charged droplets which coat the medical device. In alternate embodiments, a swirl atomizer, a pressure atomizer, an ultrasound atomizer, a rotary atomizer, and an effervescent atomizer are used to atomize the coating material.

Abstract: In order to minimize the potential for damage to bio-compatible and/or therapeutic-containing stent coatings, there is provided a compliant elastic sheath over layer between a non-compliant stent expansion balloon and an unexpanded stent, which is secured over the balloon with a securing crimp. This stent deployment assembly, which is mounted on a catheter, is maneuvered through a patient's body to a desired deployment site and then inflated to expand the stent to the desired diameter. During expansion, the compliant elastic material between the stent and the non-compliant balloon prevents non-compliant balloon-induced damage to the stent's coating, as well as preventing degradation of the non-compliant balloon by, for example, stent-caused punctures. The deflated non-compliant stent expansion balloon and compliant elastic sheath are then withdrawn from the patient's body, leaving the deployed stent at the desired implantation site with its coating substantially intact.

Abstract: In order to minimize the potential for damage to bio-compatible and/or therapeutic-containing stent coatings, there is provided a compliant elastic sheath over layer between a non-compliant stent expansion balloon and an unexpanded stent, which is secured over the balloon with a securing crimp. This stent deployment assembly, which is mounted on a catheter, is maneuvered through a patient's body to a desired deployment site and then inflated to expand the stent to the desired diameter. During expansion, the compliant elastic material between the stent and the non-compliant balloon prevents non-compliant balloon-induced damage to the stent's coating, as well as preventing degradation of the non-compliant balloon by, for example, stent-caused punctures. The deflated non-compliant stent expansion balloon and compliant elastic sheath are then withdrawn from the patient's body, leaving the deployed stent at the desired implantation site with its coating substantially intact.

Abstract: A method for holistic project management may include presenting a graphical user interface for a user to enter project information for a project. The method may also include determining a priority for the project based on an impact of the project to each of a plurality of predetermined drivers.

Abstract: An apparatus and method for spray deposition of small targets, such as medical devices like stents. The apparatus includes a spray nozzle body which has a fine bore diameter to pressurize the coating material within the nozzle body thereby dampening vibration of the nozzle body during operation and stabilizing the spray coating plume. In another embodiment, a coating method is disclosed in which a finer atomized spray droplet size is achieved by pre-filming the coating material onto a flat face before entraining the coating material within the atomizing fluid, which improves manufacturing repeatability, reduces coating variances, and increases therapeutic dosage predictability. In certain embodiments of the invention, the coating materials include therapeutic agents and biologically active materials.