Abstract: Aspects herein relate to apparatus and methods for coating medical devices. In an embodiment, a coating system is included having a two-part fluid applicator defining a central channel, the two-part fluid applicator can include a first part having a first degree of flexibility; and a second part having a second degree of flexibility. The system can further include a fluid supply conduit in fluid communication with the fluid applicator; and a fluid supply reservoir in fluid communication with the fluid supply conduit. Other embodiments are also included herein.

Abstract: Embodiments herein relate to medical devices and coatings for the same. In an embodiment, a drug delivery coating can be included having a polymeric layer. The polymeric layer can include a hydrophilic outer surface. The drug delivery coating can also include an active agent layer disposed over the polymeric layer. The active agent layer can include a microcrystalline active agent and a cationic agent. Other embodiments are also included herein.

Abstract: Embodiments of the invention include apparatus and methods for coating drug coated medical devices. In an embodiment, the invention includes a coating apparatus including a coating application unit. The coating application unit can include a fluid applicator having a lengthwise axis and a width. The fluid applicator can include a tip comprising a first face across the width of the fluid applicator. The first face of the fluid applicator can be oriented at an angle of from about 15 to about 75 degrees with respect to the lengthwise axis of the fluid applicator. The fluid applicator can define a second face intersecting the first face. The coating apparatus can further include a rotation mechanism and an axial motion mechanism. Other embodiments are also included herein.

Abstract: Aspects herein relate to coating apparatus and methods for coating medical devices. In an embodiment, a coating system is included having a valve, a fluid supply reservoir in fluid communication with the valve, a reciprocating positive displacement pump in fluid communication with the valve, and a fluid applicator in fluid communication with the three-way valve. The valve can be configured to assume a first fluid transport state and a second fluid transport state, wherein the valve provides fluid communication between the fluid supply reservoir and the reciprocating positive displacement pump when in the first fluid transport state for filling of the reciprocating positive displacement pump, and wherein the valve provides fluid communication between the reciprocating positive displacement pump and the fluid applicator when in the second fluid transport state for applying a coating suspension to a medical device surface. Other embodiments are also included herein.

Abstract: Embodiments herein relate to a system for coating rotatable medical devices and related methods. In an embodiment, a coating system for coating rotatable medical devices is included. The coating system can include a rotation mechanism, wherein the rotation mechanism is configured to mount and rotate a rotatable medical device. The coating system can also include a fluid applicator unit. The fluid applicator unit can include a rotating retention sleeve, the rotating retention sleeve defining a channel, wherein the rotatable medical device fits within the channel. The fluid applicator unit can also include a retention sleeve drive mechanism, wherein the retention sleeve drive mechanism is configured to rotate the rotating retention sleeve. The coating system can also include an inner collar, wherein the inner collar fits within the channel of the rotating retention sleeve. Other embodiments are also included herein.

Abstract: The present invention relates to a pharmaceutical composition for intravascular delivery of a therapeutic agent, such as paclitaxel, rapamycin, or an analog thereof. The composition includes the therapeutic agent and a biocompatible solvent, such as glycofurol. The composition can aid tissue penetration by the therapeutic agent. A catheter assembly that protects the pharmaceutical composition from the surroundings can be used for its intravascular delivery.

Abstract: Embodiments of the invention include apparatus and methods for coating medical devices. In an embodiment, the invention includes a coating apparatus including a coating application unit including a fluid applicator; a first rotation mechanism and a second rotation mechanism; and a controller, wherein the controller causes the first rotation mechanism and the second rotation mechanism to rotate a medical device at substantially the same speed, wherein the speed is greater than 500 rotations per minute. In an embodiment, the invention includes a method of coating a medical device including rotating a medical device with a rotation mechanism at a speed of greater than 500 rotations per minute; contacting the medical device with a fluid applicator; and applying a coating solution to the device. In an embodiment, the invention includes a medical device. In some embodiments a surface of a shaft of the device comprises high points and low points.

Abstract: A coating apparatus for coating the balloon portion of a balloon catheter is described. The coating apparatus includes a rotatable member in which the catheter portion of the balloon catheter is mounted and fixed, and which causes rotation of the balloon catheter. The apparatus also includes a support member in which the distal tip of the catheter is inserted and free to rotate; and a spray nozzle directing sprayed material on the balloon surface. The inventive configuration of the coating apparatus allows the balloon catheter to be rotated along its axis with insubstantial or no wobble, which significantly improves the quality of the coating applied to the surface of the balloon.

Abstract: Aspects herein relate to coating apparatus and methods for coating medical devices. In an embodiment, a coating system is included having a valve, a fluid supply reservoir in fluid communication with the valve, a reciprocating positive displacement pump in fluid communication with the valve, and a fluid applicator in fluid communication with the three-way valve. The valve can be configured to assume a first fluid transport state and a second fluid transport state, wherein the valve provides fluid communication between the fluid supply reservoir and the reciprocating positive displacement pump when in the first fluid transport state for filling of the reciprocating positive displacement pump, and wherein the valve provides fluid communication between the reciprocating positive displacement pump and the fluid applicator when in the second fluid transport state for applying a coating suspension to a medical device surface. Other embodiments are also included herein.

Abstract: Embodiments of the invention include bioactive agent eluting devices. In an embodiment the invention includes a bioactive agent delivery device including a substrate, a hydrophilic polymer disposed on the substrate, and a substantially amorphous bioactive agent disposed on the surface of the hydrophilic polymer. In an embodiment, the invention includes a method of making a bioactive agent delivery device including depositing a hydrophilic polymer on a substrate forming a hydrophilic surface and depositing a substantially amorphous bioactive agent on the hydrophilic surface. In an embodiment, the invention includes a bioactive agent-eluting catheter including a catheter shaft and an expandable balloon disposed on the catheter shaft. Other embodiments are included herein.

Abstract: Aspects herein relate to apparatus and methods for coating medical devices. In an embodiment, a coating system is included having a two-part fluid applicator defining a central channel, the two-part fluid applicator can include a first part having a first degree of flexibility; and a second part having a second degree of flexibility. The system can further include a fluid supply conduit in fluid communication with the fluid applicator; and a fluid supply reservoir in fluid communication with the fluid supply conduit. Other embodiments are also included herein.

Abstract: Embodiments of the invention include apparatus and methods for coating drug coated medical devices. In an embodiment, the invention includes a coating apparatus including a coating application unit. The coating application unit can include a fluid applicator having a lengthwise axis and a width. The fluid applicator can include a tip comprising a first face across the width of the fluid applicator. The first face of the fluid applicator can be oriented at an angle of from about 15 to about 75 degrees with respect to the lengthwise axis of the fluid applicator. The fluid applicator can define a second face intersecting the first face. The coating apparatus can further include a rotation mechanism and an axial motion mechanism. Other embodiments are also included herein.

Abstract: A catheter assembly includes an expandable and collapsible structure having an outer surface. The expandable and collapsible structure is adapted to expand between a contracted state and a dilated state. A coating is disposed on the outer surface of the expandable and collapsible structure. The coating includes a bioactive agent. A sleeve is disposed over the coating. The sleeve is adapted to expand between a compressed state and an enlarged state and to return to the compressed state. The sleeve defines a plurality of openings in the compressed state. An outer diameter of the coating is less than an outer diameter of the sleeve when the expandable and collapsible structure is in the contracted state and greater than the outer diameter of the sleeve when the expandable and collapsible structure is in the dilated state.

Abstract: Embodiments herein include apparatus and methods for coating medical devices. In an embodiment, a coating apparatus is included having a coating application unit including a movement restriction structure, a fluid applicator having a lengthwise major axis, a fluid distribution bar having a body angled with respect to the major lengthwise axis of the fluid applicator between 0 and 20 degrees, a rotation mechanism and an axial motion mechanism. The axial motion mechanism configured to cause movement of at least one of the coating application unit and the rotation mechanism with respect to one another. Other embodiments are also included herein.

Abstract: A coating apparatus for coating the balloon portion of a balloon catheter is described. The coating apparatus includes a rotatable member in which the catheter portion of the balloon catheter is mounted and fixed, and which causes rotation of the balloon catheter. The apparatus also includes a support member in which the distal tip of the catheter is inserted and free to rotate; and a spray nozzle directing sprayed material on the balloon surface. The inventive configuration of the coating apparatus allows the balloon catheter to be rotated along its axis with insubstantial or no wobble, which significantly improves the quality of the coating applied to the surface of the balloon.

Abstract: Embodiments herein include apparatus and methods for coating medical devices. In an embodiment, a coating apparatus is included having a coating application unit including a movement restriction structure, a fluid applicator having a lengthwise major axis, a fluid distribution bar having a body angled with respect to the major lengthwise axis of the fluid applicator between 0 and 20 degrees, a rotation mechanism and an axial motion mechanism. The axial motion mechanism configured to cause movement of at least one of the coating application unit and the rotation mechanism with respect to one another. Other embodiments are also included herein.

Abstract: A coating apparatus for coating the balloon portion of a balloon catheter is described. The coating apparatus includes a rotatable member in which the catheter portion of the balloon catheter is mounted and fixed, and which causes rotation of the balloon catheter. The apparatus also includes a support member in which the distal tip of the catheter is inserted and free to rotate; and a spray nozzle directing sprayed material on the balloon surface. The inventive configuration of the coating apparatus allows the balloon catheter to be rotated along its axis with insubstantial or no wobble, which significantly improves the quality of the coating applied to the surface of the balloon.

Abstract: Embodiments of the invention include medical device elements formed from polymers with lubricious properties. In an embodiment, a method of forming a medical device element is included. The method can include mixing a first polymeric component and a second polymeric component to form a polymer mixture. The method can further include forming the polymer mixture into the medical device element. The method can also include treating the polymer mixture with at least one of an acid or a base. In an embodiment, a medical device is included. The medical device can include a lubricious element, the lubricious element comprising a mixture of a first polymeric component and a second polymeric component. The second polymeric component can include a polymer that is treated with at least one of an acid or a base after formation of the element. Other embodiments are also included herein.

Abstract: Embodiments herein include apparatus and methods for coating medical devices. In an embodiment, a coating apparatus is included having a coating application unit including a movement restriction structure, a fluid applicator having a lengthwise major axis, a fluid distribution bar having a body angled with respect to the major lengthwise axis of the fluid applicator between 0 and 20 degrees, a rotation mechanism and an axial motion mechanism. The axial motion mechanism configured to cause movement of at least one of the coating application unit and the rotation mechanism with respect to one another. Other embodiments are also included herein.

Abstract: Embodiments of the invention include bioactive agent eluting devices. In an embodiment the invention includes a bioactive agent delivery device including a substrate, a hydrophilic polymer disposed on the substrate, and a substantially amorphous bioactive agent disposed on the surface of the hydrophilic polymer. In an embodiment, the invention includes a method of making a bioactive agent delivery device including depositing a hydrophilic polymer on a substrate forming a hydrophilic surface and depositing a substantially amorphous bioactive agent on the hydrophilic surface. In an embodiment, the invention includes a bioactive agent-eluting catheter including a catheter shaft and an expandable balloon disposed on the catheter shaft. Other embodiments are included herein.