Valve introducer systems and methods for implanting heart valve prostheses are disclosed, where a valve introducer includes an adjustable deployment mechanism comprising a deployment element and an implantation depth controlling element having a distal end and an adjustable length. The valve introducer also includes a tubular member having a distal end, configured to deliver a heart valve prosthesis, and a length extending from a fixed reference point. The implantation depth controlling element can comprise an inner and an outer cylinder, such as where the outer cylinder has interior threads, and the inner cylinder has exterior threads. The adjustable deployment element can include a depth gauge, wherein the depth gauge indicates the length the tubular member extends beyond a fixed reference point. In certain embodiments, the adjustable deployment element can also be configured to be secured to a cannula.

A method for accessing a mitral valve that includes forming an incision and inserting a first catheter comprising a lumen. The first catheter is adapted to be directed towards a left atrium and the first catheter has a working length of approximately 15 cm to approximately 52 cm. The method further includes utilizing a trocar in the first catheter to penetrate a pericardium and utilizing the trocar to penetrate the left atrium. The method further includes accessing the mitral valve from an antegrade direction.

A delivery device for percutaneously delivering a stented prosthetic heart includes a sheath, a handle, and adjustment device including a fine adjustment mechanism, and an outer stability shaft. The sheath defines a lumen and is configured to compressively constrain the stented prosthetic heart valve. The handle is coupled to the proximal portion of the sheath and includes an actuator mechanism coupled to a proximal portion of the sheath that is configured to selectively move the sheath relative to the housing to release the stented prosthetic heat valve. The adjustment device is coupled to the handle and includes an adjustment lumen through which the sheath and the handle slidably extend. The outer stability shaft is coupled to the adjustment device. The fine adjustment mechanism is configured to selectively move the handle and the sheath relative to the adjustment device and the outer stability shaft.

A heart valve repair system includes a delivery sheath and an implant that includes a frame having a surface configured to contact an upstream surface of a native heart valve. First and second gripping members are coupled to the frame and each (1) includes first and second arms and (2) is configured to clamp a respective native leaflet. The implant is disposed in the sheath in a delivery state in which the frame defines a wall fully surrounding a central longitudinal axis of the implant. The distal end of the wall defines a distal opening of the frame. The distal end of the wall is disposed proximally to the entire first tissue-engaging surface of each of the gripping members and proximally to the entire second tissue-engaging surface of each of the gripping members. Other embodiments are also described.

Aspects of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such aspects can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some aspects can include a sheath with inner and outer layers having at least one folded portion of the inner liner. Some aspects include the inner liner having etched, unetched, and otherwise surface-modified portions. Aspects of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel, thus offering advantages over prior art introducer sheaths.

Examples of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such examples can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some examples can include a sheath with inner and outer layers, where a folded portion of the inner layer extends through a slit in the outer layer and a portion of the outer layer overlaps the folded portion of the inner layer. Some examples include an elastic outer cover positioned outside the outer layer. Examples of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel, thus offering advantages over prior art introducer sheaths.

The heart valve assessment systems described herein advantageously provide indicators of a heart valve condition, such as a pressure gradient or a valve regurgitation index. The heart valve assessment systems can provide indicators of a heart valve condition during a heart procedure. A pressure gradient indicates a severity or measurement of the narrowing (or stenosis) of a valve by the increase in pressure behind it. A valve regurgitation index indicates a leakiness measurement of a valve.

Example heart valves are disclosed. An example heart valve may comprise an expandable framework configured to shift from a closed configuration to an expanded configuration, the expandable framework having an inflow end, an outflow end and a lumen extending therein. The heart valve may also include a plurality of valve leaflets coupled to the expandable framework, each of the plurality of valve leaflets including a root edge and a free edge. Further, the heart valve may also include an outer skirt coupled to the plurality of valve leaflets, the outer skirt including a proximal edge, wherein the root edge of each of the plurality of valve leaflets is attached to the proximal edge of the outer skirt.

A prosthetic apparatus for implantation in a native heart valve includes a main body for placement within the native annulus. The main body is compressible to a radially compressed state for delivery into the heart and is self-expandable from the compressed state to a radially expanded state for implantation. A valve structure is mounted within a lumen of the main body and preferably forms three leaflets made of pericardium. Ventricular anchors are coupled to a ventricular end portion of the main body. The ventricular anchors are adapted to be straightened for delivery to the native heart valve and are biased to spring back to a pre-formed bent shape for capturing the native heart valve leaflets between the main body and the ventricular anchors. An atrial sealing member may be provided along an atrial portion of the main body for impeding the flow of blood between the main body and the native annulus.

A sheath is transluminally introduced a sheath into an atrium of a heart of a subject. A guide member is advanced out of the sheath and to a chorda tendinea of the heart, the guide member having a proximal portion that includes a longitudinal element, and a distal portion that includes a helical chord-engaging element. The chord-engaging element is wrapped around the chorda tendinea. While the chord-engaging element remains wrapped around the chorda tendinea, (i) the chord-engaging element is slid over the chorda tendinea toward a papillary muscle that is coupled to the chorda tendinea; and (ii) subsequently, a tool is moved out of the sheath and toward the papillary muscle by sliding the tool along the longitudinal element. Other embodiments are also described.