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: The disclosure provides plaque treatment catheter assemblies for the treatment of arterial plaques and removal of clots. One assembly includes a second catheter tube movable within a first catheter tube, and an expansion member movable within the second tube. The second catheter tube has one or more distally-disposed and outwardly-expandable plaque treatment portion(s). Another assembly includes a catheter tube and at least one channel(s) within the catheter. The channel includes an elongate member with a distally-disposed plaque scoring or clot retrieval member. Optionally, the assembly includes an expandable member that can cause movement of the scoring member.

Abstract: A hemodialysis vascular access device includes a proximal end sized and shaped to sealably couple to a hemodialysis catheter, a movable structure coupled to the proximal end, a fixation structure coupled to the movable region and sized and shaped for fixation on a patient, an elongated sleeve coupled to the fixation structure and sized and shaped for insertion into a patient's vasculature, and a valve at a distal end of the internal lumen. When a hemodialysis catheter is inserted into the device and coupled to the proximal end, distal movement of the proximal end relative to the fixation structure biases a distal end of the hemodialysis catheter from a position inside the elongated sleeve through a valve out of the device and into the patient's blood.

Abstract: The disclosure provides macrolide particulates including a macrolide therapeutic agent such as rapamycin at high concentration in the particulate. In one method the particulates are made by adding a composition containing an polyoxyethylene sorbitan n-acyl ester, poly(ethyleneimine), or alkylated quaternary ammonium salt to a composition including macrolide dissolved in an alcohol such as ethanol. In another method the particulates are made by adding a non-solvent composition to a composition including macrolide and an alkyl-substituted chromanol dissolved in an alcohol such as ethanol. The formed macrolide particulates have one or more desirable properties including sizes in the range of 0.1 ?m to 10 ?m, spherical or near spherical shapes, low polydispersity, and/or stability. The macrolide particulates can be used for therapeutic compositions, or in association with an implantable or insertable medical device, such as associated with a polymeric coating on a device.

Abstract: Aspects herein relate to a medical device for providing a leak-resistant seal for use in a vascular access device. In various embodiments, a device for vascular access hemostasis is included. The device can include an enclosure configured to at least partially receive a medical device, the enclosure defining a cavity. The enclosure can have a first seal portion and a second seal portion, the cavity disposed between the first seal portion and the second seal portion. The enclosure can include the second seal portion comprising a split, septum seal. The enclosure can include a barrel in structural communication with the second seal portion. The device can include a constriction ring disposed around the barrel, the constriction ring interfacing with the second seal portion to limit movement of the split, septum seal.

Abstract: Embodiments herein include coated medical devices and coatings with salt groups. In an embodiment, a coated medical device is included, the coated medical device including a substrate and a polymeric layer disposed over the substrate. The polymeric layer includes a polymer and has an exterior surface. The coated medical device further includes a plurality of salt groups bonded to the polymer of the polymeric layer and disposed on the exterior surface of the polymeric layer. The salt groups can be the reaction product of a reactive group with an acid or base. In an embodiment, a method of making a medical device is included. Other embodiments are also included herein.

Abstract: Described herein is a linking agent that includes a polymeric or non-polymeric core molecule and one or more photoreactive groups covalently attached to the core molecule by one or more linking elements that include a urea linkage, a carbamate linkage, or a combination thereof.

Abstract: Described herein is a degradable linking agent of formula Photo1-LG-Photo2, wherein Photo1 and Photo2 independently represent at least one photoreactive group and LG represents a linking group comprising one or more silicon atoms or one or more phosphorous atoms. The degradable linking agent includes a covalent linkage between at least one photoreactive group and the linking group, wherein the covalent linkage between at least one photoreactive group and the linking group is interrupted by at least one heteroatom. A method for coating a support surface with the degradable linking agent, coated support surfaces and medical devices are also described.

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 devices and coatings for devices including coated hydrophobic active agent particles. In an embodiment, the invention includes a drug delivery device including a substrate; and coated therapeutic agent particles disposed on the substrate, the coated therapeutic agent particles comprising a particulate hydrophobic therapeutic agent; and a cationic agent in contact with the particulate hydrophobic therapeutic agent. Other embodiments are also included herein.

Abstract: Embodiments of the invention include drug delivery coatings and devices including the same. In an embodiment, the invention includes a drug delivery coating including a polymeric layer. The polymeric layer can include a hydrophilic outer surface. The coating can also include a matrix contacting the hydrophilic outer surface. The matrix can include a particulate hydrophobic therapeutic agent and a cationic agent. The polymeric layer can further include a hydrophilic polymer having pendent photoreactive groups and a photo-crosslinker including two aryl ketone functionalities. Other embodiments are also included herein.

Abstract: Embodiments of the invention include wound packing devices and methods of making and using the same. In an embodiment, the invention includes a wound packing device including a plurality of spacing elements comprising a nanotextured surface. The wound packing device can also include a connector connecting the plurality of spacing elements to one another. Other embodiments are also included herein.

Abstract: Embodiments of the disclosure include coatings comprising an oligomerized polyphenol layer. The oligomerized polyphenol layer can be used as an intermediate coated layer on a medical device that hydrogen bonds to a synthetic or natural polymer, which in turn can be used as a top coat or further associated with another coated layer. The multilayered coatings can provide properties such as hemocompatibility or lubricity. In other embodiments, the oligomerized polyphenol layer is used on a medical device as a hemostatic layer configured to contact blood and promote coagulation. The oligomerized polyphenol layer can also be used on the inner surface (e.g., inner diameter) of a medical device to prevent bacterial adherence. The oligomerized polyphenol layer can also be used on the surface of a in vitro diagnostic article, or a cell culture device to, promote adsorption of a biological molecule.

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.

Abstract: Disclosed herein is a delivery composition for administering a hydrophobic active agent. In one embodiment, a delivery composition for local administration of a hydrophobic active agent to a tissue or organ of a patient is disclosed. In one embodiment, the delivery composition includes a cationic delivery agent, a therapeutically effective amount of a hydrophobic active agent and a pharmaceutically acceptable aqueous carrier. In one embodiment, the cationic delivery agent includes polyethyleneimine (PEI). In a more specific embodiment, the cationic delivery agent includes branched PEI. Methods of making the delivery composition, as well as kits and methods of use are also disclosed.

Abstract: A biocompatible polymeric controlled release matrix barrier structure for delivery of one or more bioactive agents from an implantable medical device is described. In an embodiment, a biocompatible polymeric controlled release matrix barrier structure is included. The biocompatible polymeric controlled release matrix can include a body structure formed of a compliant material comprising one or more compliant biocompatible polymers and one or more bioactive agents. The body structure can define a central aperture through which a subcutaneous element of an implantable medical device passes. Other embodiments are included herein.

Abstract: Described herein is a degradable linking agent of formula Photo1-LG-Photo2, wherein Photo1 and Photo2 independently represent at least one photoreactive group and LG represents a linking group comprising one or more silicon atoms or one or more phosphorous atoms. The degradable linking agent includes a covalent linkage between at least one photoreactive group and the linking group, wherein the covalent linkage between at least one photoreactive group and the linking group is interrupted by at least one heteroatom. A method for coating a support surface with the degradable linking agent, coated support surfaces and medical devices are also described.