A catheter balloon includes a membrane having a proximal end and a distal end. A plurality of substrates are bonded about the membrane. The ability of a bond's ability to withstand repeated stresses during use may be improved by using a reinforcement or a stress relief, while also minimizing the overall thickness of the balloon proximate to its distal end. The reinforcement may comprise a portion of an unassembled membrane. Alternatively, the reinforcement may comprise an adhesive-margin tip. The stress relief may be a serpentine portion of a distal tail of a substrate.

Embodiments of the invention include apparatus and methods for coating drug coated medical devices. In an embodiment, the invention includes a coating apparatus including a coating application unit. The coating application unit can include a fluid applicator having a lengthwise axis and a width. The fluid applicator can include a tip comprising a first face across the width of the fluid applicator. The first face of the fluid applicator can be oriented at an angle of from about 15 to about 75 degrees with respect to the lengthwise axis of the fluid applicator. The fluid applicator can define a second face intersecting the first face. The coating apparatus can further include a rotation mechanism and an axial motion mechanism. Other embodiments are also included herein.

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.

This patent document discloses perfusion catheters and related methods for treating complications related to CTO interventions or dilating a vessel occlusion while maintaining a passage through the treated vessel segment. A perfusion catheter can include an inflatable balloon coiled in a helical manner around a central axis into a series of windings. An inner surface of the series of windings, when inflated, can define a passage through the inflatable balloon. A catheter can also include an elongate shaft extending from a proximal portion to a distal portion, having an inner surface that defines a lumen for providing inflation fluid to, or withdrawing inflation fluid from, a distal end of the inflatable balloon. A catheter can further include a guidewire support tube including a lumen, separate from the lumen from the elongate shaft and the passage through the inflatable balloon, for receiving a guidewire.

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.

Patient specific medical balloons, assemblies, and systems for forming the same, and devices and methods for treating patients in need of a percutaneous coronary intervention (PCI) are disclosed. The assembly for forming the medical balloon comprises a form for receiving a parison where the form is configured to prepare a patient specific medical balloon matched in geometry to a blood vessel or a lesion for a patient in need of a PCI.

A method, system and device for securing conductive material on catheter elements for tissue sensing and cryogenic ablation. This may be used to deposit or embed conductive material onto or within polymeric materials. The method of manufacturing a balloon with conductive material may include extruding a polymeric material where the polymeric material includes embedded electrically conductive material. At least a portion of the polymeric material may be removed to expose at least a portion of the embedded electrically conductive material. The benefits may include allowing local bipolar recordings, contact assessment and ice thickness, and compatibility with 3-dimensional electroanatomical mapping systems.

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.

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.

An apparatus for performing a balloon dilation procedure at the site of a stenosis or for deploying a stent in a patient, the apparatus including a single lumen catheter having a proximal end and a distal end, and a high pressure balloon attached to the distal end of the catheter. The high pressure balloon is fabricated from a semi-compliant material that has an average rated burst pressure of between about 15 and about 27 atmospheres of pressure and exhibits a dumbbell-shaped outer periphery when inflated to a first atmospheric pressure and a substantially linear outer periphery when inflated to a second atmospheric pressure.