PROSTHESIS FOR ATRAUMATICALLY GRASPING INTRALUMENAL TISSUE AND METHODS OF DELIVERY

• US 20170340440A1
• Filed: 08/11/2017
• Published: 11/30/2017
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Ratz, J. Brent, Quadri, Arshad, Pesce, Luca
• Granted Patent: US 10,716,664 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthesis can comprise an expandable frame, a plurality of distal anchors and a plurality of proximal anchors. The anchors can extend outwardly from the frame. The frame can be configured to radially expand and contract for deployment within a body cavity. The frame and anchors can have one of many different shapes and configurations. For example, when the frame is in an expanded configuration, the proximal anchors can extend a significant distance away from the exterior of the frame, such as a length equal to or greater than about one half the diameter of the frame. As another example, the anchors can have looped ends.

Claims

1. A replacement heart valve prosthesis for deployment in a native mitral valve, comprising:

a collapsible and expandable frame portion having a proximal end, a distal end and a longitudinal axis extending therethrough;

a valve body attached to the expandable frame, the valve body including a plurality of leaflets configured to allow blood to flow from the proximal end to the distal end of the frame and to inhibit flow from the distal end to the proximal end of the frame;

a plurality of proximal anchors attached to the frame portion and extending radially outwardly for deployment in a left atrium;

a plurality of distal anchors attached to the frame portion and extending radially outwardly for deployment in a left ventricle; and

a skirt comprising;

a distal portion extending along an exterior of the frame portion and along the distal anchors; and

a proximal portion extending along the proximal anchors, wherein an end of the proximal portion is positioned further radially outwardly from the longitudinal axis than the distal anchors and wherein the entirety of the proximal portion of the skirt is spaced distally from the proximal end of the frame portion.

2. The prosthesis of claim 1, wherein the proximal portion comprises an annular ring.

3. The prosthesis of claim 1, wherein at least some of the proximal anchors and/or distal anchors comprise looped ends.

4. The prosthesis of claim 3, wherein at least some of the anchors comprising looped ends are connected to the expandable frame portion at a first base and a second base spaced apart from each other.

5. The prosthesis of claim 1, wherein the expandable frame portion, the plurality of proximal anchors and the plurality of distal anchors are formed from a single piece of material.

6. The prosthesis of claim 1, wherein the distal anchors extend toward a ventricular side of the native mitral valve annulus when deployed within the native mitral valve.

7. The prosthesis of claim 6, wherein the distal anchors are positionable within the ventricle and extend proximally to ends spaced distally from the native mitral valve annulus.

8. The prosthesis of claim 6, wherein the distal anchors are positionable within the ventricle and extend proximally to ends that engage the native mitral valve annulus.

9. The prosthesis of claim 6, wherein the proximal anchors atraumatically engage tissue on an atrial side of the native mitral valve annulus.

10. A replacement heart valve prosthesis for deployment at a native mitral valve, the prosthesis comprising:

an expandable frame portion comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the expandable frame portion comprising a plurality of cells configured to collapse radially for delivery and to expand radially upon deployment;

a valve body attached to the expandable frame, the valve body comprising a plurality of leaflets configured to open to allow flow in a direction from the proximal end to the distal end of the frame and to close to inhibit flow in a direction from the distal end to the proximal end of the frame;

a proximal anchoring portion extending from the expandable frame portion and expandable from a collapsed configuration to an expanded configuration, wherein when the proximal anchoring portion is in an expanded configuration at least a portion of the proximal anchoring portion extends radially outwardly in a direction generally perpendicular to the longitudinal axis, the portion of the proximal anchoring portion that extends radially outwardly being sized and shaped to contact an atrial side of a native valve annulus;

a distal anchoring portion extending from the expandable frame portion and expandable from a collapsed configuration to an expanded configuration, the distal anchoring portion comprising a plurality of distal anchors, wherein when the distal anchoring portion is in an expanded configuration at least a portion of each distal anchor extends radially outward from the expandable frame portion; and

a skirt annularly positioned around an exterior of the expandable frame portion to create an axial barrier to fluid flow exterior to the expandable frame portion when deployed within the body cavity, the skirt comprising a proximal portion and a distal portion,

wherein when the expandable frame is in an expanded configuration;

the proximal portion extends radially outward from the expandable frame portion at a location spaced from the proximal end of the expandable frame portion, wherein at least a portion of the proximal portion is positioned further radially outward from the longitudinal axis than the ends of the distal anchors; and

the distal portion extends proximally from an inner edge of the proximal portion and turns to extend distally, at least a portion of the distal portion being positioned between the expandable frame portion and the distal anchoring portion.

11. The prosthesis of claim 10, wherein the proximal portion of the skirt is configured to extend along at least a portion of the proximal anchoring portion, the proximal portion of the skirt being configured to contact the atrial side of a native mitral valve annulus.

12. The prosthesis of claim 10, wherein the distal portion of the skirt is configured to extend along at least an inwardly facing surface of the proximal anchoring portion, the distal portion of the skirt being configured to contact the native mitral valve.

13. The prosthesis of claim 10, wherein the proximal portion of the skirt extends in a direction generally perpendicular to the longitudinal axis.

14. The prosthesis of claim 10, wherein the proximal portion of the skirt forms an annular ring.

15. The prosthesis of claim 10, wherein the entirety of the proximal portion of the skirt is positioned distal of proximal ends of the cells.

16. A replacement heart valve prosthesis for deployment at a native heart valve, the prosthesis comprising:

an expandable frame portion comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the expandable frame portion comprising a proximal row of foreshortening cells and a distal row of foreshortening cells, the foreshortening cells configured to collapse radially for delivery and to expand radially upon deployment, the expandable frame portion being configured to longitudinally foreshorten upon radial expansion;

a plurality of proximal anchors extending from the expandable frame portion and expandable from a collapsed configuration to an expanded configuration, each of the proximal anchors extending from junctions between the proximal row of foreshortening cells, wherein in an expanded configuration, ends of the plurality of proximal anchors are positioned radially outwardly relative from the expandable frame portion and extend in a direction substantially perpendicular to the longitudinal axis, the ends being axially positioned distal of the proximal end of the expandable frame portion;

a plurality of distal anchors extending from the expandable frame portion and expandable from a collapsed configuration to an expanded configuration, wherein in an expanded configuration, ends of the plurality of distal anchors are positioned radially outwardly relative from the expandable frame portion and the axial length between the base and the ends is less than a length of the cells of the distal row when in an expanded configuration; and

a skirt annularly positioned around an exterior of the expandable frame portion to create an axial barrier to fluid flow exterior to the expandable frame portion when deployed within the body cavity, the skirt comprising;

a generally cylindrical portion having a proximal end and a distal end; and

a ring-shaped portion extending radially outward from the frame at a location axially spaced from the proximal end to prevent axial flow of fluid around an exterior of the prosthesis, the ring-shaped portion comprising an inner edge extending from the proximal end of generally cylindrical portion of the skirt, the ring-shaped portion extending radially outwardly from the inner edge to an outer edge.

17. The prosthesis of claim 16, wherein the expandable frame portion comprises a plurality of longitudinally extending struts, wherein one or more of the longitudinally extending struts extends distally from an apex of a foreshortening cell and comprises at least one eyelet extending through the longitudinally extending strut for attaching a valve to the expandable frame.

18. The prosthesis of claim 16, wherein the foreshortening cells comprises diamond-shaped cells.

19. The prosthesis of claim 16, wherein each of the proximal anchors are connected to the expandable frame portion at a first base and a second base spaced apart from each other.

20. The prosthesis of claim 19, wherein bases of adjacent proximal anchors extend from a same corner of a foreshortening cell.