The present disclosure is directed to a device. The device may include a distal shaft defining a central lumen and an orienting element comprising at least one inflatable member. Wherein a first portion of the orienting element extending from the shaft in a first direction and a second portion of the orienting element extending from the shaft in a second direction. Further, wherein the second direction is substantially opposite the first direction.

Disclosed is a pericardiocentesis needle component (10), comprising a guide wire (13) and a puncture needle (12). The guide wire (13) extends into and through the puncture needle (12), and the guide wire (13) comprises a bent section (32) at the distal end and a straight section at the proximal end. The bent section (32) at the distal end is formed by bending the guide wire (13), and the end of the bent section is a pointed-shape structure. The guide wire (13) is made of a highly elastic material. The pointed end rotates at least 90 degrees within a range of no more than 3 mm starting from the pointed end at the bent section (32) of the guide wire. The pericardiocentesis needle component (10) of the present invention is less likely to damage a heart during a pericardiocentesis procedure.

Apparatus and methods are described including inserting a tool into a blood vessel, and, while the tool is within the blood vessel, acquiring an extraluminal image of the blood vessel. In the extraluminal image of the blood vessel, a location of a portion of the tool with respect to the blood vessel is detected automatically. In response to detecting the location of the portion of the tool, a target portion of the blood vessel that is in a vicinity of the portion of the tool is designated automatically. Using the extraluminal image, quantitative vessel analysis is performed on the target portion of the blood vessel. Other embodiments are also described.

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 a exterior portion of the catheter configured to the 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.

Novel and unique medical devices and associated methods are disclosed, for a medical device for puncturing tissue at a tissue site. The medical device is an elongate member having a proximal section, a distal section, and a rail section therebetween. The medical device includes an active tip at a distal end of the distal section and is operable to deliver energy to create a puncture through the tissue. The rail section is configured to both act as a rail for supporting installation of one or more tubular members thereupon, as well as be maneuverable for enabling access to the tissue site.

An atherectomy system that utilizes an anchoring balloon with a rotary debulker and a crossing balloon to remove or debulk lesions formed on the interior wall surface of a body vessel. The system may include a first balloon coupled to a first tubular member, a rotary debulker coupled to a second tubular member, a second balloon coupled to both the third tubular member and the axially moveable fourth tubular member such that the second balloon is disposed inside the third tubular member. Methods for operating this device are also provided.

A fixation device for securing together leaflets of a heart valve is provided. The fixation device may comprise two plates that are disposed on either side of the tricuspid valve. The plates may be secured to one another by a locking clip, thereby securing the valve leaflets between the plates.

A system can include an elongated member that includes a proximal portion and a distal portion that includes an agitator. The elongated member can extend through a working channel of an endoscope placed within a patient such that the agitator extends past a distal end of the endoscope into a target region within the patient. The agitator can include a plurality of disruption elements that can be in a low-profile state when within the working channel of the endoscope and can transition to an expanded state when advanced past the distal end of the endoscope. The plurality of disruption elements can define an empty cage configuration when in the expanded state. The system can include a driver coupled to the proximal portion of the elongated member. The driver can rotate the elongated member about a longitudinal axis of the elongated member.

A vascular device is provided having a catheter body and a rotatable cutter assembly located at the distal end of the catheter body. The cutter assembly has at least one helical cutting surface within a housing that is coupled by a torque shaft to a drive mechanism. A conveyor mechanism helically wound about the torque shaft conveys occlusive material conveyed into the housing by the helical cutting blade further proximally along the catheter body for discharge without supplement of a vacuum pump. The catheter body is manipulated to insert the distal end of the catheter body within a body lumen and advance the distal end of the catheter body toward the occlusive material. The drive mechanism is operated to rotate the helical cutting surface to cut and convey the occlusive material from the body lumen proximally into the housing and to convey the occlusive material conveyed into the housing by the helical cutting surface further proximally along the catheter body by the conveyor mechanism for discharge without supplement of a vacuum pump. The distal end of the catheter body is deflected and rotated to sweep the cutter assembly in an arc about the center axis of the catheter body to cut occlusive material in a region larger than the outside diameter of the cutter assembly.

The present disclosure is directed to a shuttle apparatus for detachably joining a catheter to a guidewire so that the joined catheter, extending alongside the guidewire, is in sliding engagement with the guidewire without extending around the guidewire. The apparatus comprises a collar member sized for mounting in sliding engagement around a length of the guidewire, the collar member having a longitudinal axis that approximately aligns along the length, when mounted thereabout, the length being defined between a proximal-most point of the guidewire and a distal point of the guidewire, the distal point being offset proximally from a distal-most point of the guidewire. The apparatus further comprises a plug member coupled to the collar member, the plug member having a longitudinal axis, and the plug member being sized to fit within an opening of the catheter for detachable engagement therewith.