Abstract: A system and method for treating heart failure of a patient by occluding blood flow from the azygos vein to the superior vena cava while allowing blood to flow through a shunt from the right pulmonary artery to the azygos vein. The system can include an occluder with an expandable cage positioned in the azygos vein to selectively control the flow of blood to the superior vena cava. The occluder can expand and collapse based on pressure measurements received from implanted pressure sensors.

Abstract: Disclosed are a catheter-based “kissing balloon” systems and methods of connecting blood vessels or creating an access path between blood vessels. The system includes a first delivery or passing catheter in a first vessel and a second receiving catheter in a second vessel that cooperate to create a path between the vessels. A passing catheter balloon is arranged to mate with or “kiss” a receiving catheter balloon to align the vessels before a piercing element is extended to puncture both vessels and optionally puncture a balloon. A guidewire is delivered through a lumen of the piercing element, and a distal end of the guidewire is trapped in a cage of the receiving catheter. The guidewire can then be used to deliver additional implanted devices while the passing catheter, receiving catheter, or both are removed.

Abstract: A prosthesis for placement within a native heart valve preferably includes an expandable frame having locking tabs disposed along a proximal end. A plurality of distal anchors is disposed along a distal end of the frame. Each distal anchor is provided with a cushion cover. An outer fabric member surrounds the frame and may extend outwardly from the frame in an expanded condition for providing an improved seal in the region of a native annulus. A valve body is positioned within an interior of the expandable from for allowing blood flow in only one direction. In preferred embodiments, the cushions are positioned over enlarged head portions of the distal anchors for further reducing trauma on surrounding tissue.

Abstract: A self-expanding prosthetic heart valve includes an inner frame and an outer sealing frame. A lower region of the outer sealing frame is coupled to a lower region of the inner frame. At least a portion of the outer frame has a D-shape cross-section for conforming to a shape of a native heart valve annulus. Elongate anchors are positioned outwardly from the outer sealing frame for anchoring to native leaflets. Preferably, the native leaflets are secured between the anchors and an outer surface of the outer sealing frame. A valve body is positioned within an interior lumen of the inner frame and provides a one-way valve mechanism for replacing the function of the native leaflets. For additional stability, a further anchoring mechanism may extend from the inner frame for attachment to a heart wall. The prosthetic heart valve is well-suited for replacing the function of a native tricuspid valve.

Abstract: A prosthesis for placement within a native heart valve preferably includes an expandable frame having locking tabs disposed along a proximal end. A plurality of distal anchors is disposed along a distal end of the frame. Each distal anchor is provided with a cushion cover. An outer fabric member surrounds the frame and may extend outwardly from the frame in an expanded condition for providing an improved seal in the region of a native annulus. A valve body is positioned within an interior of the expandable from for allowing blood flow in only one direction. In preferred embodiments, the cushions are positioned over enlarged head portions of the distal anchors for further reducing trauma on surrounding tissue.

Abstract: A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.

Abstract: Methods for delivering a replacement heart valve include advancing a delivery system through a femoral vein and into the atrium of a heart, wherein the delivery system includes an outer sheath assembly, a mid shaft assembly and an inner assembly. The outer sheath assembly and the mid shaft assembly are adapted to retain the replacement heart valve in a radially compacted state over the inner assembly. The outer sheath assembly is retracted to allow a plurality of distal anchors to self-expand while a portion of the replacement heart valve remains retained in a compacted state by the mid shaft assembly. The distal anchors are positioned to engage one or more native leaflets and the retained portion of the replacement heart valve is then released and allowed to fully expand for implanting the replacement heart valve within the native valve.

Abstract: A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.

Abstract: A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.

Abstract: A computer system is provided that includes one or more processors configured to define a virtual model of a workspace that is world-locked to a three-dimensional environment by a pair of anchor points. The one or more processors are configured to adjust a fit of the virtual model to the workspace by adjusting a position of a virtual component of the virtual model relative to the pair of anchor points. The one or more processors are configured to receive telemetry data including position information indicating a location of a telemetry event relative to the pair of anchor points in the workspace, and determine a visualization model based on the virtual model of the workspace, and project telemetry data to the visualization model based on a mapping of a pair of points in the visualization model to the pair of anchor points in the virtual model.

Abstract: A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.

Abstract: A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.

Abstract: A method for detecting presence of protein or biofilm on a surface includes applying a composition to the surface, and observing a color reaction if protein or biofilm is present on the surface. The composition comprises a first part that includes copper sulfate and a second part that includes a reagent capable of reacting with the copper sulfate to produce a visible color reaction when contacted with protein or biofilm.

Abstract: A replacement heart valve has an expandable frame configured to engage a native valve annulus and a valve body mounted to the expandable frame. The valve body can have a plurality of valve leaflets configured to open to allow flow in a first direction and engage one another so as to close and prevent flow in a second direction, the second direction being opposite the first direction.