Heart valve prostheses having multiple support arms and methods for percutaneous heart valve replacement

Abstract

Prosthetic heart valve devices and associated methods for percutaneous or transcatheter heart valve replacement are disclosed herein. A heart valve prosthesis configured in accordance herewith includes a frame having a valve support and a plurality of support arms extending therefrom. The plurality of support arms may include a main support arm configured to extend from the valve support for capturing at least a portion of a valve leaflet of a native heart valve therebetween when the valve prosthesis is in an expanded configuration and deployed within the native heart valve. In addition, the plurality of support arms may include multiple supplemental support arms disposed about the circumference of the valve support that when deployed in the expanded configuration are configured to at least partially engage subannular tissue at the native heart valve.

1 - 20 . (canceled) 
     
     
         21 . A heart valve repair device, comprising:
 a support having an upstream end and a downstream end with respect to a longitudinal axis of the support;   a radially-extending segment extending outwardly from the upstream end of the support and having a generally circular cross-section shape, wherein the radially-extending segment includes a plurality of interconnected self-expanding struts, and wherein the radially-extending segment is configured to expand within an atrial space proximate to an annulus of a mitral valve to engage supra-annular tissue; and   a leaflet capture arm having at least a portion extending from the downstream end of the support in a radially outward and upstream direction,   wherein the leaflet capture arm comprises a first arm segment forming a first loop and a second arm segment forming a second loop, and in a deployed state, the leaflet capture arm is resiliently biased toward an exterior surface of the support and configured to extend behind a native leaflet of the mitral valve to engage the native leaflet between the leaflet capture arm and the exterior surface of the support.   
     
     
         22 . The heart valve repair device of  claim 21  wherein, in the deployed state, the leaflet capture arm is configured to extend around a posterior leaflet of the mitral valve and extend between chordae tendinea of the mitral valve. 
     
     
         23 . The heart valve repair device of  claim 21  wherein the first loop formed by the first arm segment is an inner loop and the second loop formed by the second arm segment is an outer loop, and the first arm segment extends in an upstream direction from the downstream end of the support, and wherein the leaflet capture arm further comprises a sealing material extending across the second loop to form a tent-like cushioning structure. 
     
     
         24 . The heart valve repair device of  claim 23 , wherein the outer arm segment is coupled to the support at a first attachment point and a second attachment point, wherein the outer arm segment defines the second loop, and the outer loop extends in an upstream direction from the downstream end of the support. 
     
     
         25 . The heart valve repair device of  claim 23 , wherein the outer arm segment is integral with struts of the support, and wherein the second loop extends in an upstream direction from the downstream end of the support. 
     
     
         26 . The heart valve repair device of  claim 21 , wherein the leaflet capture arm comprises an arm body radially off-set from the support by a curved region, and wherein the arm body has an atraumatic end portion spaced apart from the curved region. 
     
     
         27 . The heart valve repair device of  claim 26 , wherein the curved region defines a reflection angle between the arm body and the external surface of the support and the arm body, and wherein the reflection angle is selected such that, when implanted at the mitral valve, the arm body engages outward-facing leaflet tissue while the atraumatic end portion does not interact with a ventricular wall behind the native leaflet, and the reflection angle is between −10° and 45°, wherein 0° represents a vertical disposition of the arm body parallel to the external wall of the support and a negative angle is in a direction toward the support. 
     
     
         28 . The heart valve repair device of  claim 21 , wherein the plurality of struts of the radially-extending segment join at crowns, and wherein the crowns have atraumatic tips. 
     
     
         29 . The heart valve repair device of  claim 21 , wherein the support, the radially-extending segment, and the support arm are separate components coupled together to form a frame structure. 
     
     
         30 . The heart valve repair device of  claim 21 , wherein the radially-extending segment has an S-shape extending from the support that defines a tissue engaging region for contacting supra-annular tissue. 
     
     
         31 . The heart valve repair device of  claim 21 , wherein the radially-extending segment is a flange or brim configured to engage supra-annular tissue. 
     
     
         32 . The heart valve repair device of  claim 21 , further comprising a sealing material extending around the support. 
     
     
         33 . The heart valve repair device of  claim 21 , wherein the plurality of interconnected self-expanding struts of the radially-extending segment define a web forming a cylindrical structure for contacting supra-annular tissue. 
     
     
         34 . A heart valve repair device, comprising:
 a support structure having a first end portion and a second end portion with respect to a longitudinal axis of the support, wherein the support structure is configured to be positioned between native leaflets of a mitral valve;   a supra-annular engagement segment comprising a plurality of interconnected struts extending laterally outwardly from the first end portion of the support and curving upwardly away from the support to an atraumatic end portion, wherein the supra-annular engagement segment has an outer tissue engagement surface configured to engage supra-annular tissue proximate to the mitral valve; and   a leaflet capture arm extending radially outward from the second end portion of the support and configured to extend behind on of the native leaflet of the mitral valve in a deployed state, wherein the leaflet capture arm comprises a first arm segment forming a first loop and a second arm segment forming a second loop.   
     
     
         35 . The heart valve repair device of  claim 34 , wherein the supra-annular engagement segment is configured to extend completely around the mitral valve in the deployed state. 
     
     
         36 . The heart valve repair device of  claim 34  wherein the supra-annular engagement segment has a non-cylindrical cross-section. 
     
     
         37 . The heart valve repair device of  claim 34  wherein, in the deployed state, the leaflet capture arm is directed radially inward toward an exterior wall of the support thereby configured to trap and engage the native leaflet between the leaflet capture arm and the exterior wall of the support. 
     
     
         38 . A method of repairing a native mitral valve of a patient, the method comprising:
 delivering a support of a heart valve repair device to a position between a posterior leaflet and an anterior leaflet of the native mitral valve, wherein the support comprises multiple interconnected struts, a first end portion, and a second end portion, and wherein the first end portion is positioned proximate to a left atrium and the second end portion is positioned proximate to the left ventricle;   expanding a supra-annular engagement segment of the heart valve repair device within the left atrium such that an outer tissue engagement surface presses against and engages supra-annular tissue within the left atrium, wherein the supra-annular engagement segment extends laterally outwardly from the first end portion of the support and comprises multiple interconnected struts that form at least a portion of the outer tissue engagement surface; and   extending a leaflet capture arm extending from the second end portion of the support behind the native posterior leaflet, wherein the leaflet capture arm comprises a first arm segment forming a first loop and a second arm segment forming a second loop.