Intravascular devices and methods for intramural delivery of dissection fluids and infusates are disclosed herein. In some embodiments, the systems include an infusion assembly that can access a position in vessel adjacent an infusion site and advance a tissue manipulation component into the infusion site to deliver a therapeutic infusate. The infusion site can be an intraluminal space, such as within an obstructive material, adjacent the obstructive material, and/or within a boundary layer between the obstructive material and a vessel wall. The infusion assembly can further deliver an infusate that includes a therapeutic drug or other agent into the infusion site.

Systems and methods for localized drug delivery via undulating drug coated balloons (DCB), in particular using functionalized nanoparticles as a drug delivery medium in combination with an undulating balloon, are disclosed. In various disclosed embodiments, a nanoparticle matrix is adhered to in an external substrate-surface, such as the balloon surface, and is activated for release once at the treatment site. Activation for release may be enhanced through the use of an undulating balloon system including methodologies for precise control of timing, waveform and extent of undulations.

The balloon catheter of the present invention is provided with a balloon base at a front end of a tubular catheter body having a predetermined length. The balloon base includes a cylindrical base having a larger diameter than an outer diameter of the catheter body, and a lumen having substantially the same diameter as the outer diameter of the catheter body is formed on the base over an entire length with both ends opened. A central axis of the lumen is inclined at a predetermined angle with respect to a central axis of the base concentric with a central axis of the catheter body, and an outer peripheral surface is formed in parallel with the central axis of the base. The balloon is provided on the outer peripheral surface of the parallel base to obliquely inflate with respect to the central axis of the catheter body during inflation.

An endoluminal punch and introducer sheath are described wherein the endoluminal punch comprises a guidewire lumen through which a user is capable of placing a guidewire. The endoluminal punch system further comprises a mechanism affixed to the hub which is capable of controlling the axial positioning of the guidewire relative to the endoluminal punch distal end. The control mechanism can be released so that the endoluminal punch can be removed from a patient while retaining the guidewire in place within the patient. The endoluminal punch introducer, including a sheath and dilator, can comprise energy emitting electrodes or transducers for cutting larger size holes in stubborn (friable, scarred, or fibrotic) tissue. In other embodiments, the endoluminal punch can comprise a guidewire or stylet, wherein the guidewire or stylet is capable of emitting energy to cut through tissue.

The subject guide catheter extension/pre-dilatation system includes an outer delivery sheath, an inner member extending within the sheath, and a mechanism for engagement/disengagement of the inner member to/from the sheath. The inner member is configured with a tapered distal tip having a delivery micro-catheter and a pre-dilatation balloon member attached to the tapered distal tip in proximity to the micro-catheter. The outer delivery sheath and the inner member are modified for different engagement/disengagement mechanisms operation. The delivery micro-catheter provides for an improved crossability for the balloon member to the treatment site in an atraumatic, expedited and convenient fashion. During the cardiac procedure, a guidewire and a guide catheter are advanced to the vicinity of the treatment site within a blood vessel. Subsequent thereto, the inner member and outer delivery sheath, in their engaged configuration, are advanced along the guidewire inside the guide catheter towards the site of treatment. Once at the treatment site, the balloon member is inflated for pre-dilatation treatment. Subsequently, the inner member is disengaged and retracted from the outer delivery sheath, and a stent is delivered to the treatment site inside the outer delivery sheath.

Disclosed are a multi-guidewire balloon dilatation catheter structure, a dilatation catheter mechanism and a medical device. The multi-guidewire balloon dilatation catheter comprises a balloon, a first guidewire channel, a second guidewire channel and a third guidewire channel. The first guidewire channel is at least partially passed through the balloon. The second guidewire channel is at least partially located at the distal end of the balloon. The third guidewire channel is at least partially located at the proximal end of the balloon. In the multi-guidewire balloon dilatation catheter structure of this embodiment, each guidewire channel can be used for accommodating the guidewire by providing the first guidewire channel and the second/third guidewire channel to assemble various devices on the single catheter of the present invention, thereby realizing simultaneous execution of device guidance, plaque cutting, guidewire anchoring, etc. The structure is simple and good in use effect.

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 device for introduction into a body vessel includes a shaft (105), a balloon (115) positioned at the distal end of the shaft (105), and at least one longitudinal scoring wire (135) to score a vascular lesion attached to the distal end of the shaft (105), disposed over the balloon (115). The shaft (105) includes a support (119), such as a wire or tube having one or more spirally cut portions (119A, 119B), which improves pushability and trackability, thereby allowing for use with an external guidewire in a “short rapid exchange” (SRX) format. The balloon (115) expands when fluid is delivered to the balloon (115) through the inflation lumen. This expansion pushes the scoring wire and guidewire against the vascular lesion.

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.

A balloon catheter includes a shaft inserted into a body; a balloon attached to the shaft on a distal end side and is expandable by an expansion fluid supplied from a side of a proximal end of the shaft; an elastic band wound around an outer periphery of an intermediate portion between a distal end portion and a proximal end portion of the balloon , and is configured to limit expansion of the balloon at the intermediate portion; and a covering member covering an outer periphery of the elastic band. The balloon is expandable to a maximum expansion diameter from a folded state, in accordance with pressure of the expansion fluid, the elastic band is expandable beyond the secured diameter, by being elastically deformed by the balloon expanding, and the covering member is expandable by being elastically deformed by the balloon or the elastic band expanding.