The Cleveland Clinic Foundation

Edwards Lifesciences Corporation

Jose L Navia

Ji-Feng Chen

Jose Antonio Navia

Brian L Davis

Shengqiang Gao

Samir Kapadia

Jorge Jordana

Carlos M Oberti

Samantha Stucke

Marwane Berrada

Qun Zhou

Ghassan S Kassab

Robert C Farnan

David J Horvath

Mark Scott Goodin

Torey Hovest

Richard Krasuski

Richard Geoffrion

A method for replacing a native atrioventricular heart valve includes inserting a delivery catheter into the heart with a prosthetic apparatus retained in a compressed state inside of the delivery catheter. The prosthetic apparatus includes an annular anchoring member having a mesh structure made of Nitinol and defining a plurality of circumferentially extending rows of cells. A fabric layer is attached to an inner surface of the anchoring member. An annular support member made of Nitinol is disposed within the anchoring member. The support member is attached to the anchoring member with sutures. A prosthetic valve made of biological tissue is disposed within and secured to the support member. The method further includes allowing the prosthetic apparatus to self-expand to a radially expanded state in which the anchoring member contacts tissue of the native atrioventricular valve.

Apparatus and method for replacing a diseased cardiac valve

An apparatus is provided for replacing a native cardiac valve. The native cardiac valve has at least one leaflet and is surrounded by a native cardiac valve annulus having superior and inferior aspects. The apparatus comprises a barbell-shaped, expandable anchoring member including first, second, and main body portions extending between the end portions. The main body portion includes a channel defined by inner and outer surfaces. Each of the first and second end portions has a diameter greater than the diameter of the main body portion. The first and second end portions are sized to respectively contact the superior and inferior aspects of the native cardiac valve annulus when the expandable anchoring member is in an expanded configuration. The apparatus also includes an expandable support member operably disposed within the main body portion of the expandable anchoring member, and a prosthetic cardiac valve secured within the expandable support member.

A method is provided for implanting a valve having at least one valve leaflet within the cardiovascular system of a subject. One step of the method includes preparing a substantially dehydrated bioprosthetic valve and then providing an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends. Next, the substantially dehydrated bioprosthetic valve is attached to the expandable support member so that the substantially dehydrated bioprosthetic valve is operably secured within the main body portion of the expandable support member. The expandable support member is then crimped into a compressed configuration and placed at a desired location within the cardiovascular system of the subject. Either before or after placement at the desired location, fluid or blood re-hydrates the substantially dehydrated bioprosthetic valve.

Method for implanting a cardiovascular valve

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.

Apparatuses and methods for at least partially supporting a valve leaflet of a regurgitant heart valve

Implantable cardiovascular valve

An apparatus for partially supporting a leaflet of a regurgitant heart valve comprises at least one subvalvular device including a subvalvular supporting portion including a leaflet-contacting upper supporter surface longitudinally spaced from an oppositely facing lower supporter surface. A supporter perimeter wall extends longitudinally between the upper and lower supporter surfaces, with at least a portion contacting a subvalvular cardiac wall adjacent to the heart valve. An anchor portion is adjacent to, and longitudinally spaced from, the upper supporter surface. The anchor portion includes a leaflet-contacting lower anchor surface longitudinally spaced from an oppositely facing upper anchor surface. A connector neck is interposed longitudinally between, and is directly attached to both of, the upper supporter surface and the lower anchor surface. 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 for treating regurgitation of blood flow through a diseased heart valve is provided. The diseased heart valve including an annulus, an anterior valve leaflet, a posterior valve leaflet and a subvalvular apparatus. The method includes providing an apparatus comprising a substantially annular support member, at least one infra-annular support member securely connected thereto, and at least one anchoring element associated with the at least one infra-annular support member. The method further includes attaching the substantially annular support member to the annulus of the diseased heart valve and attaching proximal and distal ends of a prosthetic chordae tendineae to the at least one anchoring element and a papillary muscle, respectively, so that the papillary muscle is caused to move medially.

Apparatus and method for treating a regurgitant heart valve

An apparatus for replacing a diseased cardiac valve is movable from a radially collapsed configuration to a radially expanded configuration. The apparatus comprises an expandable support member and a prosthetic valve secured therein. The main body portion extends between first and second end portions and includes an outer circumferential surface, a circumferential axis extending about the circumferential surface, and a plurality of wing members spaced apart from one another by an expandable region. Each of the wing members includes first and second end portions and a flexible middle portion extending between the end portions. The second end portion is integrally formed with the uyimain body portion. The first end portion is adjacent the circumferential axis and substantially flush with the outer circumferential surface in the radially collapsed configuration. The first end portion extends substantially radial to the outer circumferential surface in the radially expanded configuration.

A method for replacing a cardiac valve includes an expandable support member having oppositely disposed first and second ends, a main body portion extending between the ends, and a prosthetic valve within the main body portion. The main body portion has an annular shape for expanding into position in the annulus of the valve. The first and second ends include a plurality of upper and lower wing members movable from a collapsed condition into an extended condition for respectively engaging a first section of cardiac tissue surrounding the valve and for: engaging a portion of the native valve leaflets to pin the leaflets back against the annulus. The second end further includes at least two strut members spaced apart from each other. A respective one of the strut members is attached to at least one commissural section of the prosthetic valve to prevent prolapse of the valve leaflets.

Methods for replacing a cardiac valve

In one aspect of the present disclosure, a device for treating a regurgitant heart valve in a subject can include a flexible, elongated body having a central chordae support portion disposed between first and second arms. The first and second arms can include first and second lumens, respectively, extending longitudinally therethrough. A method of treating a regurgitant heart valve in a subject is also provided.

Device, system, and method for treating a regurgitant heart valve

An apparatus for treating cardiovascular diseases includes an expandable support member having oppositely disposed proximal and distal end portions and a main body portion between the end portions for positioning in a blood vessel. The proximal end portion of the expandable support member includes a plurality of wing members that extend from the main body portion. Each of the wing members is for engaging at least a portion of an antrum of a cardiac chamber surrounding the blood vessel. At least a portion of the expandable support member is treated with at least one therapeutic agent for eluting into the blood vessel, the cardiac chamber, and/or cardiac tissue. The expandable support member is made of wire-mesh, and at least a portion of the expandable support member may be made of a bioabsorbable material.

Apparatus and method for treating cardiovascular diseases

An apparatus is provided for treating regurgitation of blood flow through a diseased heart valve. The diseased heart valve includes an annulus, anterior and posterior valve leaflets, and a subvalvular apparatus. The apparatus includes a substantially annular support member and at least one infra-annular support member securely connected thereto. The substantially annular support member has at least a first intermediate portion, a second intermediate portion, and a posterior end portion extending between the first and second intermediate portions. The posterior end portion is dimensioned for attachment to a posterior portion of the annulus of the diseased heart valve. The at least one infra-annular support member is securely connected to the substantially annular support member at a first location. The at least one infra-annular support member is dimensioned to extend below at least one of the posterior and anterior valve leaflets and across or behind at least one subvalvular structure.

Growing community of inventors

Shaker Heights, OH, United States of America

Jose L Navia