Catheter assemblies and methods for making and using catheter assemblies are disclosed. An example a catheter assembly includes a catheter shaft and a balloon attached to the catheter shaft. The balloon includes a body and a proximal waist portion. The proximal waist portion has a proximal end. The catheter assembly also has a fiber braid including one or more individual filaments disposed along the balloon. The fiber braid has a proximal end aligned with the proximal end of the waist portion. The catheter assembly also has a polymer sleeve disposed on the catheter shaft, wherein in the polymer sleeve abuts the proximal end of the balloon waist and the proximal end of the braid.

A method of forming a balloon for a medical device is provided including extruding a cylindrical tube of silicone material, partially curing the cylindrical tube, inflating the cylindrical tube, and fully curing the balloon. The cylindrical tube is partially cured by exposing the cylindrical tube to a first ultraviolet light source. The cylindrical tube is inflated within a mold to form the balloon. The balloon is fully cured by exposing the balloon to a second ultraviolet light source.

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.

In various embodiments, a device is provided comprising a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being the same or greater than the first pressure. In various embodiments, a method comprising fabricating a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being at or greater than the first pressure, disposing the balloon on an elongate member having a lumen, placing the lumen in fluid communication with an interior volume of the balloon.

A method of forming a balloon for a surgical access device includes positioning a molding material into a channel defined in a first mold half of a mold and mounting a second mold half onto the first mold half to cover the channel and form a cavity within the mold. The first and second mold halves each includes vent holes extending therethrough that are in fluid communication with the cavity. The method also includes expanding the molding material to conform to the shape of the cavity to form a balloon including protrusions extending radially outwardly therefrom. The protrusions are formed by engagement of the molding material with the vent holes.

The present disclosure is directed toward drug coated balloons, and in particular to drug coated balloons having a drug coating layer that primarily uses therapeutic agents alone for improving the quality of treatments in which drug coated balloons are utilized. Particular aspects may be directed to drug coated balloon having an outer surface, and a drug coating layer on the outer surface of the balloon. The drug coating layer includes at least one therapeutic agent and is substantially free of excipients.

A balloon catheter which is inflated after insertion into a tubular tissue includes: a balloon catheter body made of a polymer material, which is inflatable by fluid injection; and a plurality of microneedles formed on the surface of the balloon catheter body, wherein the microneedles are formed by transferring a biocompatible polymer resin or photocurable resin, filled in intaglio patterns formed on a mold, which have a shape corresponding to a shape of the microneedles, to the surface of the balloon catheter body which is in close contact with the mold, by a thermal molding, thermal crosslinking or photocuring process.

An inflatable balloon includes a base balloon having a cylindrical section and a conical section and at least one circumferential fiber extending circumferentially around the conical section. The inflatable balloon includes a plurality of reinforcing strips in the conical section over the at least one circumferential fiber. Each reinforcing strip includes a plurality of fibers extending at an angle relative to the at least one fiber. Each reinforcing strip is positioned a set circumferential distance away from a neighboring reinforcing strip.

An inductively heated mold system enables rapid heating of the mold and rapid cooling to reduce thermal cycling times by employing an inductive coil in a heater module that inductively heats a ferromagnetic layer configured on the mold body, such as around the outside perimeter of the mold body. A cooling channel may be configured between the inductive coil and the ferromagnetic layer on the mold body to allow a fluid to be passed between the mold body and the heater module to rapidly cool the mold body for removal of the molded part. A plurality of heater modules may be employed that can be coupled together such that the cooling fluid passes through the coupled cooling channels from one module to a second module. In this way heater modules can be combined to provide an inductively heated mold system for a variety of mold body sizes, or lengths.

The method for producing a balloon catheter comprises a tubular object preparing step to prepare a tubular object having a space extending in the distal-proximal direction, a balloon preparing step to prepare a balloon, a balloon placement step to place the balloon in the tubular object and inflate the balloon, and a balloon deflating step to deflate the balloon and form a wing-shaped portion, wherein a projecting portion is placed on within a mean circle C1 centered at a center P1 of the tubular object, and a radius of the mean circle C1 is an average value of a shortest distance D1 from the center P1 of the tubular object to an inside surface P2 of the tubular object and a longest distance D2 from the center P1 of the tubular object to the inside surface P3 of the tubular object on a cross-section in the balloon placement step.