In one aspect, the present disclosure provides microparticles that are configured to release a first drug over a first time period and to release a second drug over a second time period, wherein a lag period of substantially no drug release occurs between the first and second time periods. In other aspects, the present disclosure pertains to the use of such microparticles in delivery systems and methods of treatment. In another aspect, the present disclosure pertains to drug delivery systems that comprising a folded inflatable drug delivery balloon that comprises folds and microparticles positioned within the folds.

Described here are systems and methods for delivering an active agent to target tissues of the ear, nose, or throat using an expandable member having drug crystals layered thereon, and methods for manufacturing such systems. The expandable member can be delivered to the target tissues in a low-profile configuration and expanded to contact and/or dilate surrounding tissue. Expansion of the expandable member transfers the drug crystals to the target tissues, which then act as an in situ depot that enables maintenance of a therapeutic level of an active agent for a desired time period after removal of the expandable member. Multiple expansions of a single expandable member can be employed during treatment. For example, the systems and methods can be useful when it is desired to treat multiple paranasal sinuses with a single expandable member.

A method and apparatus are disclosed for a device for creating a puncture in a tissue. The puncturing device comprising an elongate member having a puncturing portion at the distal tip. The puncturing device further includes at least one inflatable feature positioned around the outer circumference and at a distal portion of the elongate member. The puncturing device includes a lumen extending from a proximal end of the elongate member to the inflatable feature. The inflatable feature is in a fluid communication with the lumen and can be inflated to dilate the puncture in the tissue or anchor the puncturing device in a heart structure.

A single extrusion triple lumen expandable device designed 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 device includes a camera and lumens for enhanced functionality. The present invention is also directed to methods of collecting a tissue sample using the devices, described herein.

A multi-layered balloon is provided where each layer is formed such that each layer is made from tubing that optimizes the inner wall stretch thus providing maximum balloon strength. The high pressure, multi-layer balloon is provided with layers that allow for slipping, such that the balloon has a very high pressure rating and toughness, yet excellent folding characteristics. Methods for producing such multi-layer balloons using existing balloon forming equipment are also provided. The multi-layer balloons can have alternating structural and lubricating layers, or layers with low-friction surfaces. The multi-layer balloons are preferably manufactured using a variety of methods including nesting, co-extrusion, or a combination of nesting and co-extrusion. The multi-layer balloons have balloon layers having substantially similar, or the same, high degree of biaxial orientation of their polymer molecules such that each balloon layer of the multi-layer balloon will fail at approximately the same applied pressure.

A balloon catheter including an elongated catheter main body portion and a balloon provided on the distal portion of the catheter main body portion. The balloon is inflatable to expand radially outward into an inflated state and deflatable to contract radially inward into a deflated state. The catheter main body portion includes a hollow outer tube and a hollow inner tube disposed within the outer tube. The balloon includes a contact portion that contacts the outer surface of the inner tube and a vane portion protruding from the contact portion radially outward when the balloon is in the deflated state. The contact portion of the balloon includes a connecting portion that connects the balloon to the catheter main body portion.

A resiliently expandable elongate tubular spring structure, e.g., corresponding to a metal mesh type structure, mountable or mounted to a scoring balloon catheter includes multiple ring structures that are longitudinally separated from each other along portions of a balloon working region, and which are resiliently radially expandable in response to outwardly directed balloon expansion forces. Pairwise adjacent ring structures are structurally coupled and separated from each other by a scoring link, e.g., a single scoring link, configured as a traumatic structure with respect to vascular tissue, e.g., by way of having a square, trapezoidal, or raised blade tissue scoring/cutting profile. Each ring structure includes a pair of radially resiliently radially expandable annular springs, longitudinally separated from each other by a plurality of spacing elements, e.g., wire links, and which are atraumatic or substantially atraumatic structures relative to the scoring link with respect to tissue.

A stent delivery system includes an elongated shaft, a balloon and a stent. The balloon is dilatable from a contracted position to an expanded position when a fluid flows into an interior of the balloon. The stent is formed by wires that are spaced apart so that at least one gap is formed between the wires. The stent is mounted on the outer surface of the balloon when the balloon is contracted. The balloon includes a protruding portion which protrudes radially outward through the gap of the stent when the stent is mounted on the balloon and the balloon is in the contracted position. A lubricant is disposed on the outer surface of the balloon at least on a part of the protruding portion of the balloon, and an other portion of the balloon covered by the stent does not have the lubricant.

Balloon catheters for delivery of prosthetic hear valves is provided. The balloon catheters are configured to deploy a prosthetic heart valve through inflation. The balloon catheters are further configured with one or more retention bumpers to reduce or prevent migration of the prosthetic heart valve during delivery. Balloon catheters described herein are configured with substantially incompressible retention bumpers that promote longitudinal inflation fluid flow.

A balloon catheter visualization device includes a handle, an elongate shaft, and an asymmetrical balloon. The elongate shaft includes a distal end, a proximal end, and defines a lumen and a longitudinal axis extending from the proximal end to the distal end. The proximal end is coupled to the handle. The asymmetrical-shaped balloon including a distal portion and a proximal portion. The proximal portion is coupled to the distal end of the elongate shaft. The proximal portion has one or more reinforcement features including a layer of material coupled to the asymmetrical-shaped balloon and forming an outer contour at the proximal portion of the asymmetrical-shaped balloon that is asymmetrical to an outer contour of the distal portion of the asymmetrical-shaped balloon.