Inflatable medical devices and methods for making and using the same are disclosed. The devices can be medical invasive balloons, such as those used for transcutaneous heart valve implantation, such as balloons used for transcatheter aortic-valve implantation. The balloons can have high strength, fiber-reinforced walls.

One aspect of the invention provides a balloon catheter having a distal tip that does not extend distally beyond the distal end of the catheter balloon when the catheter balloon is inflated. In one embodiment, the distal end of the catheter balloon has a substantially flat profile when inflated. Other aspects of the invention provide methods of manufacturing and of using the balloon catheter. In one embodiment, the balloon catheter is used in the treatment of kidney stones.

A catheter-mounted balloon includes an inflatable chamber defining a volume expandable from a deflated state to an inflated state, the inflatable chamber having a distal transition portion, a proximal transition portion, and a cylindrical body portion disposed between the distal transition portion and the proximal transition portion. The cylindrical body portion of the inflatable chamber includes a pleat zone having a pleat when the inflatable chamber is in the deflated state. The catheter-mounted balloon further includes an electrode disposed along a wall of the inflatable chamber. The pleat traverses the electrode such that is electrode is pleated as well.

A balloon catheter is disclosed that can effectively deliver a drug to living body tissue, a method of manufacturing a balloon catheter, and a treatment method. A balloon catheter is disclosed, the balloon catheter is provided on an outer surface of a balloon with a plurality of elongate bodies which are independent crystals of a water-insoluble drug extending in an elongate form. The elongate bodies include fixed-side elongate bodies which are fixed to the outer surface side of the balloon, and top-side elongate bodies which are bent or broken from the fixed-side elongate bodies and are continuous with or independent of the fixed-side elongate bodies.

An apparatus for rolling a bladder includes a support structure, a rolling pin, and a bladder-mounting pin. The apparatus optionally includes a rolling initiator Rolling a bladder includes inserting the bladder while unrolled into an apparatus for rolling a bladder, inserting the bladder between a rolling pin and a bladder-mounting pin of the rolling machine, and rotating the rolling pin to (a) advance a portion of the bladder between the rolling pin and the bladder-mounting pin, (b) roll the portion of the bladder around the bladder-mounting pin, and (c) drive the bladder-mounting pin to rotate in an opposite direction from that of the rolling pin.

The present invention is an inflatable balloon which is enclosed by an expandable cover which becomes increasingly porous/permeable during expansion. The balloon is coated or enclosed with a matrix which contains a pharmaceutically active agent. During expansion of the balloon, the pharmaceutically active agent is released or extruded through the expandable cover into a body cavity such as an artery or vein. The present invention also provides for a method of treating a disease or condition by delivering the inflatable balloon to a particular body cavity.

The invention relates to a method for reducing the outer diameter of the balloon (1) of a balloon catheter in the non-expanded state, wherein at least one restriction element (3) is applied to at least a portion of the balloon (1) of the balloon catheter. In this way, the outer diameter of the balloon (1) is thus reduced and, moreover, its flexibility increased.

Disclosed herein is a drug-coated medical device in the form of a balloon having an inner surface and an outer hydrophobic surface, an adhesion balance layer directly on the outer hydrophobic surface of the balloon, comprising a hydrophilic polymer and/or a hydrophilic compound where the hydrophilic compound has a molecular weight of less than 1,000 Daltons, and a therapeutic layer directly on the adhesion balance layer comprising a therapeutic agent and a pharmaceutically acceptable carrier, wherein the therapeutic agent is a hydrophobic therapeutic agent with one or more hydrogen-bonding groups and is provided as discrete drug particles in the therapeutic layer, the drug particles have at least one dimension that is less than 25 .Math.m and are uniformly distributed on the surface of the balloon, and the pharmaceutically acceptable carrier is hydrophilic and has a molecular weight of less than 1,000 Daltons. A process to make the drug-coated medical device and uses thereof are also disclosed.

Catheters with weeping balloons can be used for various medical purposes. For example, in some embodiments provided herein weeping balloons are used for catheter visualization devices. In some embodiments, weeping balloons are used to deliver therapeutic agents. Weeping balloons can include openings of a selected size and shape through which a fluid gradually flows or “weeps.” The design of the openings can affect performance characteristics such as, but not limited to, fluid flow rate, tear resistance, and mitigation of counter-flow.

A device for obtaining tissue from the aerodigestive tract is provided. The device may have internal and external folds and a tissue collection surface for collecting a tissue sample from a body lumen, such as the nose or throat. The present invention is also directed to methods of collecting a tissue sample using the devices, described herein.