Novel, lubricious coatings for medical devices are disclosed. The coatings provide improved lubricity and durability and are readily applied in coating processes a low temperatures that do not deform the device. The present invention is also directed to a novel platinum catalyst for use in such coatings. The catalyst provides for rapid curing, while inhibiting cross-linking at ambient temperatures, thereby improving the production pot life of the coatings.

Disclosed is use of amlexanox or a salt thereof or a solvate thereof in preparation of a drug having an inhibitory action on the smooth muscle cells, in particular a drug for preventing and treating vascular restenosis. Further disclosed is a medical device, particularly a drug stent, the surface of which is distributed with amlexanox or the salt thereof or the pharmaceutical composition thereof. Amlexanox has an activity in inhibition of the proliferation of smooth muscle cells, has a low inhibitory property of the endothelial cell growth, is particularly suitable for applying on a medical device to prevent the incidence of vascular restenosis, while not delaying the repair of endothelium.

In a method of integrating an active pharmaceutical ingredient (API) with a thermoplastic polymer, the thermoplastic polymer and API are into a first feed port of a multi-screw extruder or the thermoplastic polymer is fed into the first feed port of a multi-screw extruder, the thermoplastic polymer is conveyed along the heated multi-screw extruder while heating the thermoplastic polymer to a melt temperature of 160° C.-280° C. prior to the thermoplastic polymer being conveyed past a second feed port and the API is fed into the second feeding port in the heated screw extruder to mix with the melted thermoplastic polymer to generate a compounded mixture containing 85-100% of the starting API content. The compounded mixture is extruded from an outlet of the heated screw extruder and cooled via a cooling device such that the compounded mixture contains 85-100% of the starting API content.

In a method of integrating an active pharmaceutical ingredient (API) with a thermoplastic polymer, the thermoplastic polymer and API are into a first feed port of a multi-screw extruder or the thermoplastic polymer is fed into the first feed port of a multi-screw extruder, the thermoplastic polymer is conveyed along the heated multi-screw extruder while heating the thermoplastic polymer to a melt temperature of 160° C.-280° C. prior to the thermoplastic polymer being conveyed past a second feed port and the API is fed into the second feeding port in the heated screw extruder to mix with the melted thermoplastic polymer to generate a compounded mixture containing 85-100% of the starting API content. The compounded mixture is extruded from an outlet of the heated screw extruder and cooled via a cooling device such that the compounded mixture contains 85-100% of the starting API content.

Provided are a drug layer applying device and a method for forming a drug layer which can quickly and easily apply or provide an appropriate amount of a drug on a surface of a medical instrument such as a balloon. A drug layer applying device that applies a drug layer on a surface of a balloon to be inserted into a living body, includes: a deformable porous body capable of holding a coating solution containing a drug and a solvent; a removal unit that is flexibly deformable and arranged alongside the porous body; and a holding base that holds the porous body and the removal unit.

Various embodiments disclosed relate to drug-coated balloon catheters for treating strictures in body lumens and methods of using the same. A drug-coated balloon catheter for delivering a therapeutic agent to a target site of a body lumen stricture includes an elongated balloon having a main diameter. The balloon catheter includes a coating layer overlying an exterior surface of the balloon. The coating layer includes one or more water-soluble additives and an initial drug load of a therapeutic agent.

Various embodiments disclosed relate to drug-coated balloon catheters for treating strictures in body lumens and methods of using the same. A drug-coated balloon catheter for delivering a therapeutic agent to a target site of a body lumen stricture includes an elongated balloon having a main diameter. The balloon catheter includes a coating layer overlying an exterior surface of the balloon. The coating layer includes one or more water-soluble additives and an initial drug load of a therapeutic agent.

Medical devices such as stents, stent grafts, and balloon catheters include a coating layer applied over a modified exterior surface of the medical device. The modified exterior surface comprises an exterior surface of the medical device subjected to a surface modification that decreases a surface free energy of the exterior surface before application of the coating layer an exterior surface. The coating layer comprises a hydrophobic therapeutic agent and at least one additive. The modified exterior surface may affect the release kinetics of the drug from the device, the crystallinity of the drug layer, the surface morphology of the coating and particle shape, or the particle size of drug of a therapeutic layer in the coating layer. For example, the effects caused by the modified exterior surface may increase the retention time and amount of therapeutic agent in tissue.

Disclosed herein are compositions to use in biofouling-resistant coatings, biofouling-resistant coatings, methods of making biofouling-resistant coatings, biofouling-resistant devices, and methods of making biofouling-resistant devices.

Disclosed herein are compositions to use in biofouling-resistant coatings, biofouling-resistant coatings, methods of making biofouling-resistant coatings, biofouling-resistant devices, and methods of making biofouling-resistant devices.