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 method for producing a balloon for a balloon catheter includes providing the balloon that has an outer surface. A solution including a solvent and a polymer is used to deposit the polymer onto the surface and form a surface coating of the polymer.

A method and apparatus are disclosed for forming a drug coating layer capable of preventing breakage of elongated drug crystals on a surface of a balloon and maintaining the drug crystals in an appropriate shape in order to act on a living body. The method includes supplying a coating solution which contains the water-insoluble drug, a water-soluble additive, an organic solvent, and water to the surface of the balloon and evaporating the organic solvent and the water to form an additive layer containing the water-soluble additive and a protruding crystal having a tip end protruding from the additive layer, cutting a surplus portion protruding from the additive layer of the protruding crystal from a part surrounded by the additive layer and forming the part surrounded by the additive layer as the elongated body, and removing the cut-out surplus portion from the drug coating layer.

Various embodiments provide a device comprising a balloon disposed at least partially along a template, the template including an aperture, wherein the template has a substantially cylindrical portion that resists deformation in a radial direction, wherein the balloon expands radially during inflation, wherein a portion of the balloon at least partially protrudes about the aperture. Other embodiments are directed toward balloons having textured surfaces.

A method of inflating a catheter balloon may include providing a balloon assembly operable to provide a balloon diameter vs. balloon pressure profile generally depicting a balloon inflation sequence providing at least one intermediate inflated diameter and a final inflated diameter of a balloon such that the balloon attains the at least one intermediate diameter at a predetermined pressure, and attains the final diameter at a final predetermined pressure that is lower than a predetermined pressure of a last intermediate pressure.

Various methods for optimizing coating of medical devices, such as balloon catheters are disclosed. One method configures catheter balloon folds based on balloon diameter and volume. Other methods include using a specifically-sized protective sheath, using a vacuum, using pressure, pulling the balloon through a coating solution, using at least one spacer or a wick between at least one fold for metering a therapeutic coating into the folds of the balloon, placing an intermediate layer between the balloon and the therapeutic coating, placing a soluble film having a therapeutic agent around the catheter balloon or inside the folds, and any combination thereof. Balloon catheters and catheter balloons having a specific folding configuration, a specifically-sized protective sheath, an intermediate layer, or a soluble film are also disclosed.

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.

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 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.

Methods and apparatus for coating a medical device are provided. In one embodiment, the method for preparing a substantially uniform coated medical device includes (1) preparing a coating solution comprising a solvent, a therapeutic agent, and an additive; (2) loading a metering dispenser with the coating solution; (3) rotating the medical device about the longitudinal axis of the device and/or moving the medical device along the longitudinal or transverse axis of the device; (4) dispensing the coating solution from the metering dispenser onto a surface of the medical device and flowing the coating solution on the surface of the medical device while the medical device is rotating and/or linearly moving; and (5) evaporating the solvent, forming a substantially uniform coating layer on the medical device.