Prosthetic heart valve systems

The present application claims priority to U.S. Provisional Application No. 61/032,185, filed Feb. 28, 2008, and titled “Prosthetic Heart Valve Systems,” the entire contents of which is incorporated herein by reference in its entirety.

The present invention relates to prosthetic heart valves. More particularly, it relates to transcatheter implants, methods, and delivery systems.

Heart valve replacement surgery involves the replacement of the native valves of the heart with a prosthetic valve. Prosthetic valves include mechanical valves involving only metals and polymers, and tissue valves that include non-synthetic, biocompatible materials such as pericardium, or bovine, equine or porcine tissue. Some patients have a relatively small aortic root due to their particular anatomy or excessive calcification. Some patients (e.g., young children) are likely to outgrow a prosthetic valve or outlive the useful life of a prosthetic valve.

U.S. Pat. No. 5,383,926 (Lock et al.) discloses a re-expandable endoprosthesis. The endoprosthesis is said to be re-expandable to accommodate vessel change.

U.S. Patent Application Publication Nos. 2003/0199971 A1 (Tower et al.) and 2003/0199963 A1 (Tower et al.) describe a valved segment of bovine jugular vein mounted within an expandable stent, for use as a replacement heart valve. Replacement pulmonary valves may be implanted to replace native pulmonary valves or prosthetic pulmonary valves located in valved conduits as described, for example, in “Percutaneous Insertion of the Pulmonary Valve”, Bonhoeffer, et al., Journal of the American College of Cardiology 2002; 39: 1664-1669.

Degenerated and stenotic valves in conduits or in valved stents potentially allow for a second valved stent implantation without the need for surgery, as described, for example, in “Transcatheter Replacement of a Bovine Valve in Pulmonary Position”, Bonhoeffer, et al., Circulation 2000; 102: 813-816. It has been proposed that sequential percutaneous pulmonary valve implantation is feasible and theoretically could delay the need for invasive surgery indefinitely, thus overcoming concerns regarding conduit longevity and risks associated with reoperation, as described, for example, in “The potential impact of percutaneous pulmonary valve stent implantation on right ventricular outflow tract re-intervention”, Coates, et al., European Journal of Cardio-thoracic Surgery 27 (2005) 536-543.

U.S. Patent Application Publication No. 2003/0199971 A1 (Tower et al.) discloses a stented valve with an ability to be reconfigured after implantation. This is identified as a feature useful in cases where a valve has been implanted in a growing patient (e.g., a child). Rather than replacing a valve periodically during the growth period, the supporting stent may be reconfigured to accommodate growth using a percutaneously introduced balloon catheter for re-engaging the stent to reconfigure the stent so that it will conform to the changes in the implantation site produced by the growth of the patient. In an article by Bonhoeffer, et al. entitled “Percutaneous Insertion of the Pulmonary Valve” J Am Coll Cardiol, 2002; 39:1664-1669, the percutaneous delivery of a biological valve is described. The valve is sutured to an expandable stent within a previously implanted valved or non-valved conduit, or a previously implanted valve. Again, radial expansion of the secondary valve stent is used for placing an maintaining the replacement valve.

Stented valve systems involving two or more components are disclosed in U.S. Patent Application Nos. 2004/0030381 A1 (Shu et al.) and 2008/0004696 A1 (Vesely et al.); U.S. Pat. Nos. 6,530,052 (Khou et al.) and 7,011,681 (Vesely et al.) and PCT Publication Nos. WO 06/0127756 A2 (Rowe et al.), WO 07/018,1820 (Nugent et al.) and WO 07/130,537 (Lock et al.). Some of these valve systems describe the reuse of a portion of their system. Some of these valve systems require the removal of an element and its replacement by a different element. It is believed that transcatheter removal of a previously implanted stented valve component creates challenges such as damage to implant site, creation of sites for thrombus/emboli formation and release, paravalvular leakage, inability to access removable elements due to tissue ingrowth and/or complex navigation, and delivery difficulties.

The present invention is directed to a heart valve that can be expanded following its implantation in a patient. In one aspect of the present invention, the expansion can accommodate the growth of a patient and the corresponding growth of the area where the valve is implanted. In another aspect, the present invention may maximize the orifice size of the surgical valve. The present invention includes expandable implantable conduits and expandable bioprosthetic stented valves. In one aspect of the invention, the valve may be adapted to accommodate growth of a patient to address limitation on bioprosthetic valve lifespans.

The heart valves of the invention may also facilitate a subsequent minimally invasive intervention for replacement of all or part of the valve system. In another aspect, the heart valves of the invention may ease the implantation process and could accommodate the use of a larger valve, which is especially useful for a patient with a small annulus (e.g., a small aortic annulus).

The heart valves of the invention have the capacity to overcome concerns regarding conduit longevity and risks associated with performing multiple surgeries in the same area of the patient. The heart valves of the present invention advantageously utilize the proven attributes of surgical valves (e.g., durability), while addressing some of the shortcomings of surgical valves. In particular, the heart valves of the invention provide the ability to expand a valve post implant, which provides a number of major advantages that have yet to be proven clinically in humans. First, surgical tissue valves are typically offered in a limited number of sizes/diameters. The post-implant transcatheter surgical valve expansion provided by the valves of the invention enables the orifice size for each surgical prosthetic valve patient to be maximized post-implant, thereby improving valve function. Second, the post-implant surgical valve transcatheter expansion provided by the valves of the invention enables the orifice for each surgical prosthetic valve pediatric patient to be adjusted post-implant, to thereby accommodate patient growth and eliminate unnecessary surgeries. Third, the post-implant transcatheter surgical valve expansion provided by the valves of the invention increases the orifice size of the surgical prosthetic valve patient to accommodate a larger transcatheter valve after failure of the surgical valve, thereby eliminating the need for surgical replacement. Fourth, the post-implant transcatheter surgical valve expansion provided by the valves of the invention enables clinicians to implant transcatheter valves inside small bioprosthetic valves with improved hemodynamic results. Fifth, the post-implant transcatheter surgical valve expansion provided by the valves of the invention may enable implantation of bioprosthetic valves into younger patients by facilitating transcatheter valve replacement once the bioprosthetic valve fails or presents severe risk of failure.

In another aspect of the invention, surgical methods are provided. In one embodiment, the method comprises implanting a surgical valve in an efficient manner. For example, some patients have a small aortic annulus. The present invention affords implantation of a valve in an undersized condition, after which the valve may be expanded to be larger in size or diameter (e.g., with a balloon), such as after the patient grows, minimizing the need for re-operation due to inadequate orifice size.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be further explained with reference to the appended Figures, wherein like structure is referred to by like numerals throughout the several views, and wherein:

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Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor

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