This patent document discloses perfusion catheters and related methods for treating blood vessel lesions and abnormalities. A perfusion catheter can include an inflatable balloon, an elongate shaft operably attached to the balloon, and an optional containment structure surrounding at least a portion of the balloon. The balloon can be inflated until its outer surface contacts a wall of a blood vessel. When inflated, the balloon's inner surface defines a passage for blood to flow. The balloon can be configured to release one or more substances formulated to treat a tissue at or near the wall of a blood vessel. In an example, the balloon can include a bioactive layer, which comprises the one or more substances, overlaying an optional base layer. In an example, the balloon can include multiple filars, at least one of which is configured to elute the one or more substances through a perforation or hole in the filar.

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.

A device and method for intravascular treatment of atherosclerotic plaque prior to balloon angioplasty which microperforates the plaque with small sharp spikes acting as serrations for forming cleavage lines or planes in the plaque. The spikes may also be used to transport medication into the plaque. The plaque preparation treatment enables subsequent angioplasty to be performed at low balloon pressures of about 4 atmospheres or less, reduces dissections, and avoids injury to the arterial wall. The subsequent angioplasty may be performed with a drug-eluting balloon (DEB) or drug-coated balloon (DCB). The pre-angioplasty perforation procedure enables more drug to be absorbed during DEB or DCB angioplasty, and makes the need for a stent less likely. Alternatively, any local incidence of plaque dissection after balloon angioplasty may be treated by applying a thin, ring-shaped tack at the dissection site only, rather than applying a stent over the overall plaque site.

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 invention relates to a balloon catheter comprising a shaft (2) extending in the longitudinal direction, which has at least a first and a second section (7, 8), with the first section (7) being arranged distal to the second section (8) and being more flexible than the second section (8), with the shaft (2) being provided with a first and a second hose-like tube (10, 11) and a balloon (3) being arranged at the distal end of the first tube (10), said balloon (3) being expandable by pressurization with a fluid led through said first tube (10), and said second tube (11) serving for accommodating a guidewire and terminating distally of said balloon (3) and being provided with an opening at said distal end, wherein both said first and second tubes (10, 11) extend along said first and second sections (7, 8), and both said first and second tubes (10, 11) are more flexible in said first section (7) than in said second section (8), wherein a transition section (9) is arranged between said first and second sections (7, 8), in which the first tube (10) has the same material properties as in the first section (7) and the second tube (11) has the same material properties as in the second section (8) or the first tube (10) has the same material properties as in the second section (8) and the second tube (11) has the same material properties as in the first section (7).

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.

Provided herein in some embodiments is an apparatus including a composite balloon with a tubular fiber layer and a polymeric balloon layer over the fiber layer. Also provided herein in some embodiments is a method including inserting a collapsed fiber tube into an expanded polymeric balloon, expanding the collapsed fiber tube to provide an expanded fiber tube, and securing an outer surface of the expanded fiber tube to an inner surface of the expanded polymeric balloon. The method can further include inserting a distal portion of an elongate catheter body through a center of the composite balloon and securing the composite balloon to the distal portion. Thereby, the method can include forming the catheter body with the composite balloon configured to apply a pressure to surrounding walls of an anatomical vessel in an inflated state of the composite balloon to modify one or more intravascular lesions in the anatomical vessel.

The present disclosure is directed toward a composite balloon comprising a layer of material having a porous microstructure (e.g., ePTFE or expanded polyethylene) and a thermoplastic polymeric layer useful for medical applications. The layers of the composite balloons become adhered through a stretch blow-molding process. Methods of making and using such composite balloons are also described amongst others.