A balloon catheter and a method are disclosed capable of suppressing the separation of a drug with which an outer surface of a balloon is coated. A balloon catheter in which a balloon with an outer surface coated with a drug is disposed to an inside of a protective tube, in which: the balloon includes a plurality of wing portions that are folded while protruding radially outward; the wing portions each include a wing distal end portion, a wing proximal end portion, and a wing middle portion; the wing distal end portion is pleated such that inner surfaces are separated from each other; and the wing distal end outer portion contacts an inner peripheral surface of the protective tube; the wing distal end inner portion includes a first contact portion that contacts a second contact portion of another wing portion.

A balloon catheter and a method for arranging a balloon are disclosed, which are capable of suppressing the separation of a drug with which an outer surface of a balloon is coated. A balloon catheter in which a balloon with an outer surface coated with a drug is disposed to an inside of a protective tube, in which: the balloon includes a plurality of wing portions that protrude radially outward, and a plurality of base portions that are in contact with an inner tube; each of the plurality of wing portions include a wing distal end portion that is positioned on a protruding side, a wing proximal end portion that is connected to the base portion, and a wing middle portion that is positioned between the wing distal end portion and the wing proximal end portion.

A folding method of an inflatable balloon disposed on an outer peripheral surface of an inner tube of a balloon catheter is disclosed. The method includes: disposing the balloon to an inner side of a plurality of first blade portions arranged so as to surround a reference position while maintaining a state where pressure is applied to an inside of the balloon; correcting a bend of the balloon by moving the plurality of first blade portions toward the reference position in the state where the pressure is applied to the inside of the balloon; pleating a plurality of wing portions protruding radially outward on the balloon by further moving the plurality of first blade portions toward the reference position to partially press the balloon while gradually discharging the fluid inside the balloon; and folding the balloon along the inner tube.

A method of fabricating a balloon catheter configuration is provided, the method comprises: preparing one catheter body, the catheter body comprises one internal tube, one external tube, and one stripping agent; the internal tube comprises one longitudinal groove and one drain passageway, wherein the longitudinal groove is configured in the exterior surface of the internal tube, the drain passageway is configured inside the internal tube, the external tube covers the internal tube, and the stripping agent is configured between the internal tube and the external tube; removing the internal tube of the catheter to allow one end of the external tube of the catheter body beyond one end of the internal tube adjacent to the external tube; folding the end of the external tube toward the axial center of the catheter; and attaching the end of the external tube to one part of the inner wall of the drain passageway.

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 disclosed.

A balloon catheter includes a balloon which is both of high strength and radiopaque. The balloon includes an outer strengthened layer which includes a strengthening element at least partially embedded within the layer. Concentrically within the strengthened layer there is a radiopaque layer which includes a high concentration of radiopaque material distributed in the radiopaque layer. The strengthened layer acts as a support to the radiopaque layer which is otherwise be unable to withstand the pressure to which the balloon is normally inflated for deployment and in the course of a medical procedure. The structure provides a high strength radiopaque balloon with a relatively thin balloon wall optimizing balloon flexibility and wrappability. There is also disclosed a method of making a balloon which uses an internal support layer in a raw tubing which is then removed following formation of a balloon.

A non-compliant fiber-reinforced medical balloon comprises a first fiber layer and a second fiber layer embedded in a continuous matrix of thermally-weldable polymer material defining a barrel wall, cone walls and neck walls. The fibers of the first fiber layer have a pattern of different lengths and are divisible into a first group and a second group based on length. The length of the fibers of the second group varies progressively in accordance to their proximity to the fibers of the first group; the fibers of the second group closest to the fibers of the first group being longer than the fibers of the second group further from the fibers of the first group. The fiber of the second fiber layer winds circumferentially around the longitudinal axis of the balloon substantially over the entire length of the balloon.

A fiber-reinforced device, such as an inflatable medical balloon, includes a cylindrical central portion. The balloon includes first and second tapered portions connected to the cylindrical central portion along a longitudinal axis extending from a first end of the balloon to a second end of the balloon. In one embodiment, the balloon includes at least one zone free of fibers extending in a longitudinal direction, such that each longitudinal fiber is discontinuous in a circumferential direction around the balloon. In another embodiment, the balloon includes alternating discontinuous and continuous longitudinal fibers. In yet another embodiment, the balloon includes discontinuous longitudinal fibers, with every other longitudinal fiber having a discontinuity aligned in a circumferential direction. Related methods are also disclosed.

Stable formulations for a dimeric naphthalimide coating and preparation methods for forming said coating, dimeric naphthalimide coated articles, as well as sterilization and storage-stable packaging thereof.

A balloon (12) having a drug carried on a working surface (W) of the balloon wall and a radiopaque identifier (30) identifying the location of the drug (D) on the balloon (12), wherein a portion of the balloon is coated with a radiopaque material to which a drug formulation adheres, and uncoated areas are not covered by the drug (D) or the drug (D) is adhered to the working surface (W), that is not treated with radiopaque material.