A catheter and methods for luminal therapy are provided wherein a catheter includes an elongated catheter shaft having a proximal end and a distal region, a first inflation lumen and a second inflation lumen extending from the proximal end to the distal region; a fluid impermeable balloon affixed to the distal region; an intermediate balloon affixed to the distal region to envelop the fluid impermeable balloon, the intermediate balloon having a first multiplicity of through-wall apertures; and an outer balloon affixed to the distal region to envelop the intermediate balloon, the exterior surface of the outer balloon comprising a coating of an agent; wherein the first inflation lumen is coupled to a first space enclosed by the fluid impermeable balloon, the second inflation lumen is coupled to a second space defined by the fluid impermeable balloon and the intermediate balloon, wherein the fluid impermeable balloon is configured to contact and expand the intermediate balloon against the outer balloon, and to expand the outer balloon such that the coating is in contact with a luminal wall. The outer balloon also may include a multiplicity of through-wall apertures.

The invention relates to a coated medical device for rapid delivery of a therapeutic agent to a tissue in seconds to minutes. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent, at least one of an oil, a fatty acid, and a lipid, and an additive. In certain embodiments, the additive has a hydrophilic part and a drug affinity part, wherein the drug affinity part is at least one of a hydrophobic part, a part that has an affinity to the therapeutic agent by hydrogen bonding, a part that has an affinity to the therapeutic agent by charge, and a part that has an affinity to the therapeutic agent by van der Waals interactions. In embodiments, the additive is at least one of a surfactant and a chemical compound. In further embodiments, the chemical compound is water-soluble.

A balloon catheter and methods of using same are provided. The balloon catheter can include an expandable structure mounted over a balloon coated with a composition. The expandable structure includes a plurality of axial struts crossing a plurality of radially-expandable rings for constraining the balloon such that isolated balloon regions can protrude through openings in the expandable structure when the balloon is inflated. The balloon catheter can be configured to maximize scraping of the composition from the surface of the balloon by the struts of the expandable structure during balloon inflation.

A balloon catheter is disclosed capable of effectively delivering a drug to living body tissue and a manufacturing method of the balloon catheter, and a treatment method. The balloon catheter has a balloon at a distal portion of a catheter shaft, and is provided on a surface of the balloon with elongate bodies which are crystals of a water-insoluble drug extending in a longitudinal direction. The surface of the balloon is provided with crystal conjugates formed of a plurality of elongate bodies united to one another while being in a tilted state.

Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a catheter. The catheter may include a catheter shaft and a balloon. The balloon may comprise a cone portion, a waist portion, and a body portion. A fiber braid may be disposed along the balloon. An inner surface of the waist portion may be thermally bonded to an outer surface of the catheter shaft and an inner surface of the fiber braid may be adhesively bonded to an outer surface of the waist portion.

Angioplasty balloons coated with at least one limus drug, which may be in crystalline form, optionally with at least one excipient, and methods for manufacturing such coated angioplasty balloons.

A balloon catheter that includes an elongated main body, a balloon connected to the elongated main body, and a base layer on the outer surface of the balloon. The base layer includes a water-soluble low-molecular weight compound. The balloon catheter also includes a plurality of elongate bodies extending radially away from the outer surface of the balloon. The elongate bodies are crystals of a water-insoluble drug. The elongate bodies each possesses an independent longitudinal axis. At least part of at least some of the elongate bodies are located in the interior of the base layer on the outer surface of the balloon.

A balloon catheter that includes an elongated main body extending in an axial direction and a balloon connected to the distal portion of the elongated main body. The balloon includes an interior and is inflatable and deflatable. The balloon catheter also includes a plurality of elongate bodies extending radially away from the outer surface of the balloon. The elongate bodies are crystals of a water-insoluble drug. The elongate bodies each possess an independent longitudinal axis. Each of the elongate bodies includes a base portion at the proximal end of the elongate body. A plurality of elongate body proximal portions extend radially inwardly from the base portion of each of the elongate bodies toward the interior of the balloon. The elongate body proximal portions are continuous extensions of the crystal of the water-insoluble drug.

A balloon catheter includes an elongated main body extending in an axial direction and a balloon connected to the elongated main body. The balloon is inflatable and deflatable in the radial direction. The outer surface of the balloon includes a plurality of recesses that are spaced apart from one another. The balloon catheter also includes a plurality of elongate bodies on the outer surface of the balloon. The elongate bodies are crystals of a water-insoluble drug extending in the radial direction of the balloon away from the interior of the balloon. The elongate bodies each possess an independent long axis. At least two elongate bodies of the elongate bodies are positioned in one of the recesses in the outer surface of the balloon. These two elongate bodies extend from within the recess to a surrounding environment in the radial direction of the balloon.

A parison for being blow molded into a medical balloon for a catheter includes a first tubular layer having a functional modification and a second tubular layer adapted for bonding with the first tubular layer to form the blow molded balloon. Related methods are also disclosed.