Abstract: Valve devices for replacement of mitral valves while preserving valvular and subvalvular mitral valve apparatus. The valve device may be configured as a double orifice valve replacement device, and may include an anchoring and manifold assembly coupleable to a delivery catheter. The assembly may include means for anchoring the device to the mitral valve or to a fixation device already attached to the mitral valve. A peripheral ring anchoring system secured to the assembly may include at least one expandable anchoring ring that is expandable within an orifice of the mitral valve so as to surround the orifice perimeter. A helical suture may be helically disposable about the ring, securing the ring to adjacent leaflet tissue. A trap door valve including a trap door body that seals against the anchoring ring during systole and unseals during the diastolic portion of the cardiac cycle may be provided.

Abstract: Disclosed are methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction. The procedures described herein can be performed with interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient's arterial or venous vasculature remote from the heart. The interventional tools and other equipment may be introduced percutaneously or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart.

Abstract: The present disclosure relates to delivery systems for delivering and deploying interventional devices to a targeted area within a body, such as delivering a replacement heart valve to a targeted heart valve. A delivery device includes a steerable catheter and a replacement valve delivery system positioned within the steerable catheter and configured to be translatable within the steerable catheter. The steerable catheter includes one or more control wires running from a distal end of the catheter to a handle at the proximal end of the catheter. Each control wire is coupled to a control of the handle such that manipulation of the control provides deflection and control of the steerable catheter.

Abstract: System for fixation of leaflets of a heart valve including an implantable fixation device including a first distal element and a second distal element, a first proximal element moveable relative to the first distal element between a first position and a second position, and a second proximal element moveable relative to the second distal element between a first position and a second position. The system further includes a delivery device including a catheter having a proximal end portion and a distal end portion, the implantable fixation device releasably coupled to the distal end portion of the catheter, the catheter defining at least one lumen extending between the proximal end portion and the distal end portion.

Abstract: An intravascular device includes a shaft having a body defining a major lumen and a plurality of minor lumen. The minor lumens are spaced about the major lumen. The major lumen and the plurality of minor lumen extend from a proximal end of the body to a distal end of the body. One or more wires may extend through the major lumen and/or minor lumen.

Abstract: The present disclosure relates to repair devices and methods for repair of regurgitant tricuspid valves. A repair method includes positioning a repair device at a tricuspid valve in a collapsed configuration. The repair device includes a proximal disk and a distal disk joined by a neck section. The distal disk is deployed by passing it from the collapsed state to an expanded configuration on a first side of the tricuspid valve. The proximal disk is then deployed by passing it from the collapsed state to an expanded configuration on a second side of the tricuspid valve so as to grasp all three tricuspid valve leaflets between the deployed distal disk and the deployed proximal disk.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, and a second arm moveable between a closed position and an open position.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, and a fixation device releasably coupled to the delivery catheter. The fixation device includes a first arm moveable between a closed position and an open position, and a second arm moveable between a closed position and an open position. The fixation device further includes a first gripping element movable relative to the first arm in the open position, the first gripping element biased toward the first arm to capture a first leaflet of the heart valve therebetween, and a second gripping element movable relative to the second arm in the open position, the second gripping element biased toward the second arm to capture a second leaflet of the heart valve therebetween.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, a second arm moveable between a closed position and an open position.

Abstract: Valve devices for replacement of mitral valves while preserving valvular and subvalvular mitral valve apparatus. The valve device may be configured as a double orifice valve replacement device, and may include an anchoring and manifold assembly coupleable to a delivery catheter. The assembly may include means for anchoring the device to the mitral valve or to a fixation device already attached to the mitral valve. A peripheral ring anchoring system secured to the assembly may include at least one expandable anchoring ring that is expandable within an orifice of the mitral valve so as to surround the orifice perimeter. A helical suture may be helically disposable about the ring, securing the ring to adjacent leaflet tissue. A trap door valve including a trap door body that seals against the anchoring ring during systole and unseals during the diastolic portion of the cardiac cycle may be provided.

Abstract: A steerable guide catheter includes a tip ring at a distal end and one or more pullwires configured to engage with the tip ring when put in tension, the pullwire(s) thereby subjecting the steerable guide catheter to a curving or turning force. The tip ring includes a saddle and one or more pullwire channels allowing the pullwire to be looped over the saddle such that when the pullwire is placed under tension, it abuts against the saddle of the tip ring. Some embodiments include additional catheters axially aligned within or outside of the steerable guide catheter, and include a keying feature aligning the rotation of the multiple catheters. The keys of the keying feature can be formed of a polyamide with a glass microsphere filler, and can be thermally welded to the catheter.

Abstract: An interventional curvature device for temporarily adjusting the structure of a heart during a heart valve repair procedure in order to enhance the effectiveness of the heart valve repair procedure. The curvature device is adjustable between a collapsed configuration with a profile suitable for delivery of the device to a coronary sinus and great cardiac vein of a patient, and an expanded configuration for lodging of the device at the coronary sinus and great cardiac vein. The curvature device has a distal section that anchors within the great cardiac vein, and a proximal section that anchors within the coronary sinus. A tether is coupled to the distal end of the device and extends through the device and past the proximal end. An increase in tension in the tether increases the curvature of the device.

Abstract: The methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. Regurgitation of an atrioventricular valve, particularly a mitral valve, can be repaired by modifying a tissue structure selected from the valve leaflets, the valve annulus, the valve chordae, and the papillary muscles. These structures may be modified by suturing, stapling, snaring, or shortening, using interventional tools which are introduced to a heart chamber. The tissue structures can be temporarily modified prior to permanent modification. For example, opposed valve leaflets may be temporarily grasped and held into position prior to permanent attachment. In one aspect, a structure is deployed in a gutter region of the valve annulus to modify the shape of the valve.

Abstract: Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

Abstract: The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

Abstract: The present disclosure relates to repair devices, repair systems, and methods for repair of regurgitant tricuspid valves. A repair method includes positioning a repair device at a tricuspid valve. The repair device includes a pair of proximal arms and a pair of corresponding opposing distal arms, with each proximal arm and corresponding opposite distal arm forming an arm pair. The arms are actuated so that leaflet tissue is grasped between the proximal and distal arms, with a first leaflet being grasped by a first arm pair and a second leaflet being grasped by a second arm pair. A suture line is anchored at the second leaflet. Then, the repair device is pivoted to grasp and suture a third tricuspid leaflet to tie the second and third leaflets together. The clip remains deployed to tie the first and third leaflets together.

Abstract: The present disclosure relates to delivery devices and interventional devices configured to enable monitoring of pressure and other hemodynamic properties before, during, and/or after a cardiac procedure. A guide catheter includes a routing lumen or a routing groove for routing a sensor wire to a desired location during a cardiac procedure. A guide catheter includes one or more pressure sensors positioned to provide desired pressure measurements when the guide catheter is deploying an interventional device. An interventional device may also include one or more associated sensors for providing hemodynamic information before, during, and/or after deployment.

Abstract: Methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. A delivery device for delivering an implantable device to a target area includes a fluid management system for directing fluid and delivery device components to the target area. The delivery device includes a grip line assembly configured to control a gripper in the implantable device for grasping tissue at the target area. The delivery device includes a lock line assembly configured to control a locking mechanism in the implantable device to lock the implantable device in a desired orientation. The delivery device includes a deployment handle configured to provide staged deployment of the implantable device. A delivery assembly includes a housing and a delivery device partially housed within the housing and being adjustable using one-handed operation.

Abstract: An intravascular device configured to be recaptured within a guide catheter has a ring located at the distal end of a delivery catheter. The ring has an outer diameter greater than that of the delivery catheter and a sloped guide surface near the outer edge of the ring to urge the ring and delivery catheter toward a radially centered position within the guide catheter.