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.

The present disclosure relates to heart valve prostheses, delivery devices, actuation handles, and other improved devices and methods that facilitate delivery of a heart valve prosthesis to a defective native valve structure in a patient, such as the aortic valve.

To provide a valve cusp sizer which is small and easy to handle. The present invention relates to a valve cusp sizer 100 for determining the size of a valve cusp depending on the size of a cardiac valve. The valve cusp sizer 100 includes a front surface 10 formed in an arcuate surface form to be abutted against an organism, a back surface 20 positioned on an opposite surface side of the front surface 10, and a pinching portion 30 protruding from the back surface 20. By removing a grip member and a grip member attachment portion from a conventional valve cusp sizer in this manner, and by forming the pinching portion 30 to be held by a clamp, tweezers, or the like, it is possible to dramatically miniaturize the valve cusp sizer while maintaining necessary functions of the valve cusp sizer.

A catheter device (2) is provided for implanting an anchor (9) into body tissue to attach a line (14) to the body tissue. The catheter device (2) comprises: a housing section (4), (8) extending from a distal end of the catheter device (2) along the length of the catheter device (2) toward the proximal end of the catheter device, the housing section (4), (8) comprising a distal part (8) at the distal end of the catheter device (2) and a proximal part 4 located on the proximal side of the distal part (8). An anchor deployment mechanism (106), (110) is provided at the distal part (8) of the housing section (4), (8) for deployment of the anchor (9) for attachment of the anchor (9) to the body tissue. The anchor (9) is held in its stowed position by the anchor deployment mechanism (106, 110) in the distal part (8) prior to deployment, and the anchor (9) comprises a number of hooks (62) for engagement with the body tissue and having a folded position and an unfolded position, wherein the anchor (9) is made of an elastic material such that the hooks (62) can be elastically deformed into the folded position by application of a constraining force, and will return to the unfolded position when no constraining force is applied, and wherein the hooks (62) are held in the folded position whilst the anchor (9) is in the stowed position within the distal part (8). The distal part (8) of the housing (4), (8) has a non-circular shape (118), (117) for engagement with a corresponding non-circular form (28), (108) of the anchor (9) and/or the anchor deployment mechanism (106), (110), such that when the anchor (9) is held in the distal part (8) movement of the anchor (9) is restrained with respect to rotation of the anchor (9) about a longitudinal axis of the distal part (8) due to engagement between the non-circular shape (118), (117) and the non-circular form (28), (108).

An expandable member that is configured to engage an interior region of a prosthetic valve and capable of transitioning from a pre-deployment configuration at a pre-deployment temperature, where the expandable member is capable of being positioned in the valve at an interior valve region when the valve is disposed in a cardiovascular structure, to a post-deployment configuration when the expandable member is subjected to cardiovascular tissue temperature, where an outer surface region of the valve proximate the interior valve region is placed in intimate contact with host cardiovascular tissue of the cardiovascular structure at a first position and seals perivalvular leaks present at the first cardiovascular structure position.

A system for treating mitral regurgitation may include an outer sheath having a lumen extending to a distal end of the outer sheath, an intermediate sheath slidably disposed within the lumen of the outer sheath, the intermediate sheath having a lumen extending to a distal end of the intermediate sheath, and an inner sheath slidably disposed within the lumen of the intermediate sheath, wherein the inner sheath includes a first anchor disposed within a lumen of the inner sheath, the first anchor being configured to penetrate and secure to a first papillary muscle. The intermediate sheath may include a tissue grasping mechanism at the distal end of the intermediate sheath, the tissue grasping mechanism being configured to hold and stabilize the first papillary muscle for penetration and securement of the first anchor to the first papillary muscle.

An apparatus for partially supporting a leaflet of a regurgitant heart valve includes at least one subvalvular device including a subvalvular supporting portion and an anchor portion. The subvalvular supporting portion and anchor portion are each at least partially formed from at least one of braided mesh strands of a first configuration, braided mesh strands of a second configuration, a balloon, a plurality of longitudinally extending struts, and a plurality of laterally extending struts. A connector neck is interposed longitudinally between, and is attached to both of, the subvalvular supporting portion and the anchor portion. The connector neck penetrates longitudinally through at least one of a base of the leaflet and an annulus of the heart valve at a manufactured puncture site.

A method and device for anchoring a prosthetic heart valve or annuloplasty ring to a valve annulus in a heart and a method of implanting same is disclosed. The device can include a prosthetic valve or annuloplasty ring with one or more anchors configured to be threaded or otherwise passed underneath a native leaflet and/or subvalvular tissue to secure the device at the native annulus.

A mitral valve prosthesis to be implanted in a heart, comprises an asymmetrical ring, the asymmetrical ring is dimensioned to mimic a native mitral annulus of a patient; an anterior flexible leaflet and a posterior flexible leaflet, said leaflets suspended from the asymmetrical ring and configured to substantially coapt with each other; and at least four sets of cords, each set of cords attached to the anterior or posterior leaflet on a first end and attached into a cap on a second end, the cap is configured to be attached onto papillary muscles of the heart on another end of the cap.

The present disclosure provides aortic valve prosthetic devices that are constructed in a non-axisymmetric shape, or are expandable to a non-axisymmetric shape for improved results in the repair of defective aortic valves. The devices can be surgically implanted, or they can be implanted percutaneously through an insertion catheter. The expandable devices can be self-expanding or expanded by an inflatable balloon to a non-axisymmetric cross-section geometry.