BACKGROUND OF THE INVENTION

The present invention relates to heart valve replacement and, in particular, to collapsible prosthetic heart valves. More particularly, the present invention relates to collapsible prosthetic heart valves that may be repositioned during a deployment procedure.

Prosthetic heart valves that are collapsible to a relatively small circumferential size can be delivered into a patient less invasively than valves that are not collapsible. For example, a collapsible valve may be delivered into a patient via a tube-like delivery apparatus such as a catheter, a trocar, a laparoscopic instrument, or the like. This collapsibility can avoid the need for a more invasive procedure such as full open-chest, open-heart surgery.

Collapsible prosthetic heart valves typically take the form of a valve structure mounted on a stent. There are two types of stents on which the valve structures are ordinarily mounted: a self-expanding stent and a balloon-expandable stent. To place such valves into a delivery apparatus and ultimately into a patient, the valve must first be collapsed or crimped to reduce its circumferential size.

When a collapsed prosthetic valve has reached the desired implant site in the patient (e.g., at or near the annulus of the patient's heart valve that is to be replaced by the prosthetic valve), the prosthetic valve can be deployed or released from the delivery apparatus and re-expanded to full operating size. For balloon-expandable valves, this generally involves releasing the entire valve, assuring its proper location, and then expanding a balloon positioned within the valve stent. For self-expanding valves, on the other hand, the stent automatically expands as the sheath covering the valve is withdrawn.

In delivery systems for self-expanding aortic valves, after the delivery system has been positioned for deployment, the annulus end of the valve may be unsheathed and expanded first, while the aortic end of the valve remains sheathed. Once the annulus end of the valve has expanded, it may be determined that the valve needs to be repositioned in the patient's aortic annulus. To accomplish this, a user (such as a surgeon or an interventional cardiologist) typically resheaths the annulus end of the valve, so that the valve can be repositioned while in a collapsed state. After the valve has been repositioned, the user can fully deploy the valve.

Once a self-expanding valve has been fully deployed, it expands to a diameter larger than that of the sheath that previously contained the valve in the collapsed condition, making resheathing impossible, or difficult at best. In order for the user to be able to more readily resheath a valve, it is preferable that the position and operation of the valve be evaluated after the valve has been only partially deployed, with a portion of the valve still collapsed inside of the sheath.

Despite the various improvements that have been made to collapsible prosthetic heart valves, conventional devices, suffer from some shortcomings. For example, in certain procedures, collapsible valves may be implanted in a native valve annulus without first resecting the native valve leaflets. The collapsible valves may have critical clinical issues because of the nature of the stenotic leaflets that are left in place. Additionally, patients with uneven calcification, bi-cuspid disease, and/or valve insufficiency could not be treated well, if at all, with the current collapsible designs.

The reliance on evenly calcified leaflets could lead to several problems such as: (1) perivalvular leakage (PV leak), (2) valve migration, (3) mitral valve impingement, (4) conduction system disruption, (5) coronary blockage, etc., all of which can have severely adverse clinical outcomes. To reduce these adverse events, the optimal valve would seal and anchor adequately without the need for excessive radial force, protrusion into the left ventricular outflow tract (LVOT), etc., that could harm nearby anatomy and physiology.

There therefore is a need for further improvements to the devices and systems of collapsible prosthetic heart valves, and in particular, self-expanding prosthetic heart valves. Among other advantages, the present invention may address one or more of these needs.

SUMMARY OF THE INVENTION

In some embodiments, a prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end. The heart valve further includes a plurality of commissure features disposed on the stent and a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to the plurality of commissure features. Each commissure feature includes a body having a proximal end a distal end, and a plurality of eyelets arranged in at least two rows and at least two columns for distributing load from the plurality of leaflets.

In some examples, each of the plurality of commissure features includes a body that is substantially rectangular. Additionally, each of the plurality of commissure features may include at least three rows of eyelets disposed on the body. Each of the plurality of commissure features may include two columns of eyelets disposed on the body. Each of the plurality of eyelets may be substantially the same shape and/or size.

In some embodiments, a prosthetic valve assembly for assembly to a collapsible and expandable stent includes a stent having a plurality of commissure features, each commissure feature including a body having a longitudinal direction extending between a proximal end and a distal end, and a plurality of eyelets arranged in a plurality of columns each extending in the longitudinal direction, the body having a width in a direction orthogonal to the longitudinal direction. The valve assembly may include a plurality of leaflets, each leaflet having a top free edge for coapting with others of the leaflets and including at least one rectangular tab foldable upon itself along a fold line for attaching to a commissure feature at a leaflet-commissure feature junction, the at least one rectangular tab having a width which is at least as long as the width of the body.

In some examples, the tab includes a distal end extending beyond the distal end of the body when the tab is aligned for attachment to the commissure feature. A flap may be coupled to one side of the tab to provide an additional buffer at the leaflet-commissure feature junction.

In some embodiments a prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end. A plurality of commissure features may be disposed on the stent, each commissure feature including a body having a longitudinal direction extending between a proximal end and a distal end, and a plurality of eyelets arranged in at least two columns extending in the longitudinal direction and at least two rows extending in a direction orthogonal to the longitudinal direction, for distributing load from the plurality of leaflets. A collapsible and expandable valve assembly may include a plurality of leaflets connected to the plurality of commissure features via a suture pattern. The plurality of eyelets may be arranged in two columns and the suture pattern forms an “X” pattern between an eyelet in a first of the column and an adjacent eyelet of a second in the columns.

