Devices, systems and methods for controlling, regulating, altering, transforming or otherwise modulating the delivery of a substance to a delivery site. The devices, systems and methods optimize the delivery of the substance to an intended site, such as a vessel, vascular bed, organ and/or other corporeal structures, while reducing inadvertent introduction or reflux substance to other vessels, vascular beds, organs, and/or other structures, including systemic introduction.

A coaxial multilumen annulus plane catheter, including an outer pigtail catheter enclosing one or two additional lumens, each housing either a slidable shaped wire or a second pigtail catheter shaped to fit into a wide range of annulus diameters and/or depths. In embodiments, the device may include a catheter delivery handle with thumb/finger-actuated sliders that extend or retract the shaped wires and are sized to enable side-to-side or radial motion, imparting a torque to the pre-shaped wires which translates the length of the wires to enable individually controlled rotation or sweep of each wire to accommodate different annulus diameters. The delivery handle includes hemostasis controls and flush ports. In other embodiments, a handle is obviated by direct lumen axial and rotational control at a proximal end.

The catheter canal is a medical device. The catheter canal is configured for use with a guiding catheter or guide sheath. The catheter canal forms a canal that controls and eliminates potentially undesirable movement of a catheter, wire, stent, balloon or any other over the wire instrument as it is inserted into a patient. The catheter canal includes a guiding structure, a plurality of flexible structures, and an adhesive structure. The plurality of flexible structures and the adhesive structure attaches to the guiding structure. The plurality of flexible structures form a framework that creates the canal that controls and limits potentially undesirable movement of the catheter, wire, stent, balloon or any other over the wire instrument.

A venous drainage cannula, catheter, or other device is in certain embodiments convertible or adjustable for application in cardiac surgery procedures involving cardiopulmonary bypass. Such a convertible cannula device can be modified, for example, for use as both a multi-stage cannula and a bi-caval cannula, so that the same device can be used in multiple different procedures where one or the other cannula type is needed. Such convertible cannula or other device can simplify and reduce a number of parts needed for a bypass procedure, by providing one adjustable and versatile device to serve multiple functions where different cannulae are traditionally required. Various embodiments further provide cannula devices where a variety of different hole or opening arrangements and configurations can be achieved, to adapt to various different procedures.

An apparatus for forming a passageway through tissue includes a dilator mounted to a shaft, wherein the dilator includes a first portion, which has an increasing taper from a first outer diameter to a larger second outer diameter, and a second portion, which has a decreasing taper from the first portion to a distal end of the dilator, and which includes an external non-cutting thread formed along the decreasing taper. Lumens of the dilator and shaft provide a conduit for means to pierce through the tissue, for example, an elongate wire that includes a piercing tip. In some cases, the dilator first portion is expandable to, and contractible from, the larger second outer diameter, wherein the apparatus may include a spreading member configured to slide between the shaft and the first portion. The apparatus may be included in a system with an introducer sheath.

The present technology relates to interatrial shunting systems and methods. In some embodiments, the present technology includes interatrial shunting systems that include a shunting element having a lumen extending therethrough that is configured to fluidly couple the left atrium and the right atrium when the shunting element is implanted in a patient. The system can also include an energy receiving component for receiving energy from an energy source positioned external to the body, an energy storage component for storing the received energy, and/or a flow control mechanism for adjusting a geometry of the lumen.

A shunt device is configured to be inserted into a puncture in a tissue wall that defines a horizontal reference plane. The shunt device includes a shunt body. The shunt body includes a central flow tube extending from a first axial end to a second axial end and defining a central axis therethrough that is angled from a reference axis extending perpendicular through the horizontal reference plane; a flow path extending through the central flow tube; and a plurality of arms extending outward from the central flow tube and configured to secure the shunt device to the tissue wall. The plurality of arms includes a first distal arm and a second distal arm attached to the first axial end of the central flow tube and a first proximal arm and a second proximal arm attached to the second axial end of the central flow tube.

Devices are provided with an internal dimension that can be reduced and increased in vivo. In one example, an interatrial shunt for placement at an atrial septum of a patient’s heart includes a body. The body includes first and second regions coupled in fluid communication by a neck region. The body includes a shape-memory material. The body defines a passageway through the neck region for blood to flow between a first atrium and a second atrium. The first and second regions are superelastic at body temperature, and the neck region is malleable at body temperature. A flow area of the passageway through the neck region may be adjusted in vivo.

A catheter pump assembly is provided that includes a proximal a distal portion, a catheter body, an impeller, and a flow modifying structure. The catheter body has a lumen that extends along a longitudinal axis between the proximal and distal portions. The impeller is disposed at the distal portion. The impeller includes a blade with a trailing edge. The flow modifying structure is disposed downstream of the impeller. The flow modifying structure has a plurality of blades having a leading edge substantially parallel to and in close proximity to the trailing edge of the blade of the impeller and an expanse extending downstream from the leading edge. In some embodiments, the expanse has a first region with higher curvature and a second region with lower curvature. The first region is between the leading edge and the second region.

Medical devices, systems and methods for occluding a left atrial appendage of a heart with an implant are provided. In one embodiment, a medical device system includes a sheath for delivering the implant. The sheath includes, at a distal portion of the sheath, first and second deflectable portions that are each independently deflectable relative to first and second pivot locations, respectively. With this arrangement, at least one of the first and second pivot locations are adjustable along a longitudinal length of the distal portion of the sheath.