Balloon catheters that includes inner and outer elongate shafts, each of which is secured relative to an end of an inflatable member. The inner and outer elongate shafts are secured relative to one another at one more discrete connection locations. The balloon bonding locations are disposed radially inward relative to an outer dimension of the outer elongate shaft.

The present disclosure is directed toward a semi-compliant to non-compliant, conformable balloon useful in medical applications. Conformable balloons of the present disclosure exhibit a low straightening force when in a curved configuration and at inflation pressures greater than 4 atm. Balloons of the present disclosure are constructed of material that can compress along an inner length when the balloon is in a curved configuration. In further embodiments, balloons of the present disclosure can be constructed of material that sufficiently elongates along an outer arc when the balloon is in a curved configuration. As a result, medical balloons, in accordance with the present disclosure, when inflated in a curved configuration, exhibit kink-free configurations and do not cause a significant degree of vessel straightening.

A catheter including one or more echogenic members facilitate guiding the catheter to a selected locations within a patient using ultrasound imaging. The echogenic members may include expandable members, such as balloons, be positioned near a distal end of the catheter. The echogenic members include an echogenic material, such as a coating or a fluid, that is configured to enhance the diffuse sound scattering of the echogenic member. An expanded echogenic member is detectable using ultrasound imaging.

A thin walled balloon formed in polymer tubing has a patterned metal layer on its outer surface, created by physical vapor deposition (PVD). The pattern is defined by a stencil mask assembled around the balloon, with the balloon inflated therein. The PVD occurs without deforming or degrading the polymer material of the balloon, by actively pulling heat away from the balloon a) by forming the stencil mask out of metal; b) by providing a metal heat conduction path away from the balloon to a heat sink, such as outside the vacuum chamber, and/or c) by flow of a cooling fluid within the balloon during the PVD process. Proper PVD process parameters are selected to minimize heat generation, such as having argon pressure in the range of 0.8 to 1.2 milli-torr and generating the plasma at a power of less than about 200 watts/ square inch of effective target surface area.

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.

Apparatus for delivering a therapeutic agent to a uterine cavity including an elongated member having a fluid channel for passage of the therapeutic agent into the uterine cavity, a dispensing member extending distally of the elongated member and having at least one perforation for passage of the therapeutic agent into the uterine cavity into contact with the endometrium. An infusion line is in communication with the fluid channel for passage of a fluid into the uterine cavity to assess leakage to determine integrity of the uterine cavity prior to passage of the therapeutic agent into the uterine cavity.

Various embodiments disclosed relate to drug-coated balloon catheters for treating, preventing, or reducing the recurrence of a stricture and/or cancer, or for treating benign prostatic hyperplasia (BPH), in a non-vascular body lumen 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. In some embodiments, the balloon catheter includes a length-control mechanism which stretches and elongates the balloon when it is in a deflated state, giving the balloon a smaller cross-sectional deflated profile for tracking through the body lumen and for removal after treatment.

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.

Treating a treatment area in the vasculature includes a first catheter adapted for positioning at the treatment area, said first catheter including a first balloon having a transient radiopaque material corresponding to the treatment area. A second catheter adapted for positioning at a treatment area includes a treatment that substantially matches the transient radiopaque material, preferably so that the length and/or position of the treatment corresponds to the length and/or position of the transient radiopaque material. Related kits, assemblies, and methods are also described.