Abstract: Devices, systems, and methods for intraluminal puncturing system are disclosed. A first catheter has a flexible positioning arm extending from a distal end thereof and being configured for delivery within an anatomical vessel. The flexible positioning arm is configured to transition between a collapsed orientation and an expanded orientation. A second catheter is disposed within the first catheter and has an opened distal end affixed to the positioning arm such that when the flexible positioning arm is in the expanded orientation, the opened distal end opposes a wall of the anatomical vessel. An elongated shaft is extendable through the second catheter. A tissue puncturer is located on a distal end of the elongated shaft. The tissue puncturer is configured for axial advancement in the second catheter and operably connected to the opened distal end of the second catheter.

Abstract: A balloon-expandable prosthetic heart valve includes a collapsible and expandable frame. The frame includes an inflow end, an outflow end, and a plurality of closed cells. Each of the closed cells includes a pair of first angled struts that converge to form a first apex, a pair of second angled struts that converge to form a second apex, and a pair of side struts extending between the first pair of angled struts and the second pair of angled struts. Each side strut has a first end and a second end, and a width of each of the side struts varies from the first end to the second end.

Abstract: A medical system for applying negative pressure within a gastrointestinal tract of a subject. The system includes a linearizing element, an elongate tube, and a fluid-tight lumen. The elongate tube includes a longitudinal channel, portals in fluid communication with the channel, and a longitudinal shape-forming wire. The elongate tube has a delivery state when associated with the linearizing element and a coiled state when dissociated therefrom. When the elongate tube is in the coil form, a proximal end of the coil forms a shoulder. At a region of the shoulder, the shape-forming wire is modified. The elongate tube has a first flexure modulus in a coil-radial direction and a second flexure modulus, greater than the first flexure modulus, in a coil-axial direction. The fluid-tight lumen is in fluid communication with the elongate tube and couples to a source of negative pressure.

Abstract: A medical system for applying negative pressure within a gastrointestinal tract of a subject, including a linearizing element, an elongate tube, and a fluid-tight lumen. The elongate tube includes a channel along a longitudinal portion, at least one portal in fluid communication with the channel, and a shape-forming wire extending along a longitudinal length of the elongate tube. The elongate tube has a delivery state when associated with the linearizing element and a first operative state when dissociated from the linearizing element, in which the elongate tube forms a coil. A rotational orientation of the shape-forming wire relative to the elongate tube is fixed throughout an entire length of the shape-forming wire. The fluid-tight lumen is in fluid communication with the elongate tube, and is adapted to couple to a source of negative pressure and to deliver negative pressure to the elongate tube.

Abstract: Devices, systems, and methods for causing retrograde oxygenated blood flow in at least a portion of the venous system of the myocardium are disclosed. Devices and methods include a method for causing retrograde oxygenated blood flow in at least a portion of the venous system of the myocardium, the method comprising: implanting a variable occluder in a coronary sinus region proximate a left atrium, wherein the variable occluder is configured to gradually increase a level of blood flow restriction over a period of days to enable a venous system of the myocardium to compensate for increased pressure caused by the gradual increase in the level of blood flow restriction; and following venous system compensation, shunting oxygenated blood flow into the coronary sinus to cause retrograde flow of oxygenated blood in at least a portion of the venous system of the myocardium to thereby enable revascularization of the myocardium.

Abstract: Devices, systems, and methods for revascularization of the myocardium are disclosed, such as an intravascular medical device for shunting and selectively regulating anatomical fluid flow. A tubular shunt is configured for deployment in a passageway between a first organ and a second adjacent organ and to bridge a first cavity in the first organ and a second cavity in the second organ. A stabilizer is configured to stabilize the tubular shunt in the passageway. A flow deflector extends from the tubular shunt and has a surface for deflecting flow in the second cavity.

Abstract: Devices, systems, and methods for intraluminal puncturing system are disclosed. A first catheter has a flexible positioning arm extending from a distal end thereof and being configured for delivery within an anatomical vessel. The flexible positioning arm is configured to transition between a collapsed orientation and an expanded orientation. A second catheter is disposed within the first catheter and has an opened distal end affixed to the positioning arm such that when the flexible positioning arm is in the expanded orientation, the opened distal end opposes a wall of the anatomical vessel. An elongated shaft is extendable through the second catheter. A tissue puncturer is located on a distal end of the elongated shaft. The tissue puncturer is configured for axial advancement in the second catheter and operably connected to the opened distal end of the second catheter.

Abstract: A prosthetic heart valve includes a collapsible and expandable annular frame. The frame includes a plurality of rows of hexagonal cells. Each of the hexagonal cells is defined by six struts, including: two opposing side struts extending parallel to each other, a first pair of angled struts extending from respective first ends of the side struts and converging to intersect with each other, and a second pair of angled struts extending from respective second ends of the side struts and converging to intersect with each other. The prosthetic heart valve can also include a valvular structure with a plurality of leaflets. The prosthetic heart valve can further include a sealing member.

Abstract: Devices, systems, and methods for causing retrograde oxygenated blood flow in at least a portion of the venous system of the myocardium are disclosed. Devices and methods include a method for causing retrograde oxygenated blood flow in at least a portion of the venous system of the myocardium, the method comprising: implanting a variable occluder in a coronary sinus region proximate a left atrium, wherein the variable occluder is configured to gradually increase a level of blood flow restriction over a period of days to enable a venous system of the myocardium to compensate for increased pressure caused by the gradual increase in the level of blood flow restriction; and following venous system compensation, shunting oxygenated blood flow into the coronary sinus to cause retrograde flow of oxygenated blood in at least a portion of the venous system of the myocardium to thereby enable revascularization of the myocardium.

Abstract: A steering tool includes an internal tube disposed inside an external tube. The internal and external tubes are arranged for longitudinal axial movement relative to one another. A distal end of the internal tube is fixedly joined to a distal end of the external tube. A tube manipulator can cause relative axial movement and distal bending of the internal and external tubes. A locking mechanism can switch between a locked position in which the internal and external tubes are locked at a particular longitudinal axial position relative to one another, and an unlocked position in which there is uninhibited free movement of the internal and external tubes relative to one another. The locking mechanism also includes an intermediate locked position in which there is partially inhibited movement of the internal and external tubes relative to one another.

Abstract: Devices, systems, and methods for causing retrograde oxygenated blood flow in at least a portion of the venous system of the myocardium are disclosed. Devices and methods include a method for causing retrograde oxygenated blood flow in at least a portion of the venous system of the myocardium, the method comprising: implanting a variable occluder in a coronary sinus region proximate a left atrium, wherein the variable occluder is configured to gradually increase a level of blood flow restriction over a period of days to enable a venous system of the myocardium to compensate for increased pressure caused by the gradual increase in the level of blood flow restriction; and following venous system compensation, shunting oxygenated blood flow into the coronary sinus to cause retrograde flow of oxygenated blood in at least a portion of the venous system of the myocardium to thereby enable revascularization of the myocardium.

Abstract: Devices, systems, and methods for intraluminal puncturing system are disclosed. A first catheter has a flexible positioning arm extending from a distal end thereof and being configured for delivery within an anatomical vessel. The flexible positioning arm is configured to transition between a collapsed orientation and an expanded orientation. A second catheter is disposed within the first catheter and has an opened distal end affixed to the positioning arm such that when the flexible positioning arm is in the expanded orientation, the opened distal end opposes a wall of the anatomical vessel. An elongated shaft is extendable through the second catheter. A tissue puncturer is located on a distal end of the elongated shaft. The tissue puncturer is configured for axial advancement in the second catheter and operably connected to the opened distal end of the second catheter.

Abstract: A method for treating a deficient native mitral valve includes advancing the distal end portion of a delivery catheter into a heart, advancing a second catheter from the first catheter, the second catheter containing a support member stretched into a linear form, and deploying the support member from the second catheter around native leaflets of the mitral valve using a pusher shaft such that the support member is disposed in a plane substantially parallel to a plane of an annulus of the native mitral valve. The support member can extend in a circumferential direction around the native leaflets and around an axis extending from a left atrium of the heart through the native mitral valve to the left ventricle.

Abstract: Devices, systems, and methods for revascularization of the myocardium are disclosed, such as an intravascular medical device for shunting and selectively regulating anatomical fluid flow. A tubular shunt is configured for deployment in a passageway between a first organ and a second adjacent organ and to bridge a first cavity in the first organ and a second cavity in the second organ. A stabilizer is configured to stabilize the tubular shunt in the passageway. A flow deflector extends from the tubular shunt and has a surface for deflecting flow in the second cavity.

Abstract: Prosthetic valve delivery assemblies including a prosthetic heart valve and a delivery apparatus. The prosthetic heart valve includes a frame having posts extending from a terminal outflow end of the frame and a valve structure disposed within the frame. The delivery apparatus includes an inner shaft including a valve connection portion having recesses configured to receive the posts of the frame of the prosthetic heart valve, an outer shaft including a valve sheath for retaining the prosthetic valve in a radially compressed state and retaining the posts within the recesses, and a handle including a control knob for moving the valve sheath proximally and distally relative to the handle. The control knob is seated within the handle housing such that the housing partially covers a circumferentially extending outer surface of the control knob.

Abstract: Prosthetic valve delivery assemblies including a prosthetic heart valve and a delivery apparatus. The prosthetic heart valve includes a frame having posts extending from a terminal outflow end of the frame and a valve structure disposed within the frame. The delivery apparatus includes an inner shaft including a valve connection portion having recesses configured to receive the posts of the frame of the prosthetic heart valve, an outer shaft including a valve sheath for retaining the prosthetic valve in a radially compressed state and retaining the posts within the recesses, and a handle including a control knob for moving the valve sheath proximally and distally relative to the handle. The control knob is seated within the handle housing such that the housing partially covers a circumferentially extending outer surface of the control knob.

Abstract: A method of treating a deficient native mitral valve includes advancing a steerable distal end portion of a first catheter through a patient's vasculature, advancing the distal end portion of the first catheter into the patient's heart to position the distal end portion of the first catheter adjacent the native mitral valve, advancing a distal end portion of a second catheter from a distal end of the first catheter, the distal end portion of the second catheter forming a second curve when advanced from the first catheter, and deploying a support structure from the second catheter such that the support structure extends around native leaflets of the native mitral valve within a left ventricle of the heart, the support structure extending in a circumferential direction around the native leaflets and around an axis extending from a left atrium of the heart through the native mitral valve to the left ventricle.

Abstract: A method treating a deficient native mitral valve includes advancing the distal end portion of a delivery catheter into a heart, wherein the delivery catheter contains a support band stretched into a linear form, wherein the support band comprises a shape-memory material, and then ejecting the support band from the distal end portion of the delivery catheter such that the support band transitions from the linear form to a curved shape extending around native leaflets of the native mitral valve.

Abstract: An intravascular retrograde blood flow device is disclosed. The device comprises a catheter; an expandable shunt compressed within the catheter and configured to bridge an opening between a first cavity of a first organ and a second cavity of a second organ; an expandable flow deflector compressed within the catheter and configured to deflect flow in the second cavity; and a flexible hinge interconnecting the expandable shunt and the expandable flow deflector. The flexible hinge is bendable to enable transverse axial positioning of the expandable shunt and the expandable flow deflector while maintaining an interconnection between the expandable shunt and the expandable flow deflector.

Abstract: A method of treating a deficient native mitral valve of a heart of a patient includes advancing a steerable, first catheter through the patient's vasculature, advancing the distal end portion of the first catheter into the heart to position the distal end portion of the first catheter adjacent the native mitral valve, adjusting the curvature of the distal end portion of the first catheter to form a first curve, advancing a distal end portion of a second catheter from a distal end of the first catheter, wherein the distal end portion of the second catheter is pre-shaped to form a second curve when advanced from the first catheter, and deploying a wire from the second catheter such that the wire extends around native leaflets of the native mitral valve.