Methods and devices are disclosed for passing Chronic Total Occlusion (CTO) from subintimal location and re-entry into a true-lumen of the patient using transient fenestration approach. The transient fenestration is induced by balloon dilatation within the CTO, and a guidewire quickly trails into a true lumen.

Some embodiments are directed to magnetic puncture access and delivery systems and methods, including creating a passageway, such as a fistula, between two vessels or segments of a vessel. A system can include two catheters, each carrying a plurality of magnets along a longitudinal axis of each catheter.

Catheter devices, assemblies and related methods for percutaneous crossing of an occlusion in a blood vessel are disclosed. A catheter device can include a central catheter, two side tubes, and a distally-protruding, curved subintimal guidewire. The central catheter can define a central lumen that extends from a proximal end to a distal end of the central catheter. The lumen can be configured to receive a primary guidewire. The central catheter can also define at least one reentry aperture oriented transverse to the central lumen. The first and second side tubes can be coupled with the central catheter, extending along a longitudinal axis thereof, with the first side tube flanking an opposite side of the central catheter relative to the second side tube. The subintimal guidewire can extend from the first side tube, distally beyond the distal end of the central catheter, to the second side tube.

A recanalization catheter assembly and method for establishing a subintimal pathway around an occlusion in a blood vessel. The recanalization catheter assembly an inflatable balloon structure including a distal anchoring portion configured to expand within a true lumen portion of the blood vessel distal of the occlusion to anchor the recanalization catheter from unintentional movement during expansion of a stent in the subintimal pathway. The expandable stent, such as a bioabsorbable stent, may be configured to promote native tissue regrowth around the stent to create a superficial intimal layer along the subintimal pathway.

Embodiments of the invention are directed towards a rapid exchange catheter configured for insertion into a subintimal space and crossing an occlusion in a subintimal space. The catheter includes a proximal end, a distal end, a first lumen configured to receive a first wire, the first lumen extending longitudinally through a least a lateral port of the catheter, and a second lumen having at least a portion distal of the lateral port and extending through at least the distal end of the catheter. The catheter also includes an exchange port, arranged on an exterior portion of the catheter configured to receive a second wire and second rapid exchange port in communication with the second lumen. Moreover, other embodiments of the invention are directed towards methods for using the rapid exchange catheter to cross an obstruction in a vessel, e.g., a total or partial occlusion, in a subintimal space.

An apparatus is provided for subcutaneous implantation in a patient using a tunneling instrument. The implantation apparatus comprises a vascular graft and a connector adapted to couple a distal end of the tunneling instrument and a proximal end of the graft. The connector comprises a tip, a first end of the tip configured to be received within the proximal end of the graft, a clip for securing the graft to the tip, and a coupler for a rotatable connection of the tip to the tunneling instrument such that the tip is rotatable about its longitudinal axis relative to the coupler to facilitate attachment of the graft to the tunneling instrument. The implantation apparatus may further comprise a removable sheath configured to substantially cover the length of the graft.

Methods and devices are disclosed for passing Chronic Total Occlusion (CTO) from subintimal location and re-entry into a true-lumen of the patient using transient fenestration approach. The transient fenestration is induced by balloon dilatation within the CTO, and a guidewire quickly trails into a true lumen.

A catheter system can include a tubular body, and at least one of a targeting system coupled to the tubular body, an expandable member, or a fluid injection port. A method of identifying a bifurcation can include inserting a catheter system into a first vessel, positioning the catheter system at a first location, expanding an expandable member to occlude the first vessel, delivering contrast material so the contrast material pooling proximate to the expandable member, and reviewing a shape of the contrast material in the first vessel under fluoroscopy.

A catheter device having a distal tube portion having a longitudinal axis and a tube wall comprising at least one side port; and a guide tip mounted on the distal tube portion, the guide tip defining: a unitary body having an outer wall, and a plurality of indentations in the outer wall, wherein the indentations are oriented substantially parallel to the longitudinal axis, and wherein each indentation extends from a distal-most end of the guide tip to a proximal region of the guide tip.

A biologics delivery device and method of use for promoting angiogenesis in occluded vessels and ischemic tissue of a patient are provided, wherein the biologics delivery device includes a catheter having a proximal end, a distal region having a distal end, a lumen extending there between, and a plurality of through-wall apertures distributed along the distal region, the plurality of through-wall apertures in fluid communication with the proximal end and the lumen, and an expandable member disposed in the distal region, the expandable member configured to transition between a collapsed state and an expanded state. Methods of using the inventive biologics delivery device also are provided to achieve substantially uniform distribution of the biologic into a subintimal space.