Prosthesis for atraumatically grasping intralumenal tissue and methods of delivery

• US 10,583,000 B2
• Filed: 04/06/2018
• Issued: 03/10/2020
• 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
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US15/947,168
• Publication Number:
  US 20180221143A1
• Time in Patent Office: 704 Days
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body

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 frame can have a larger cross-sectional dimension in a middle portion of the frame and a smaller cross-sectional dimension in a proximal portion and a distal portion of the frame, wherein the middle portion is between the proximal and distal portions. As another example, the anchors can have looped ends, the entire anchor may loop out from the frame.

Claims

1. A method for deploying a self-expanding replacement mitral valve prosthesis within a native mitral valve having a native mitral valve annulus, the method comprising:

advancing the self-expanding replacement mitral valve prosthesis into a heart in a radially compacted state, the self-expanding replacement mitral valve prosthesis comprising;

an expandable frame comprising an atrial end and a ventricular end and having a longitudinal axis extending between the atrial end and the ventricular end, the expandable frame configured to radially expand and contract for deployment within the native mitral valve, wherein when the expandable frame is in an expanded configuration, the expandable frame having a larger cross-sectional dimension in a middle portion of the expandable frame and a smaller cross-sectional dimension in a proximal portion and a distal portion of the expandable frame, the middle portion being between the proximal portion and the distal portion; and

a plurality of generally longitudinal struts extending from the atrial end, each of the plurality of longitudinal struts comprising a mushroom-shaped tab;

a plurality of ventricular anchors having ends positioned distal the middle portion, each of the plurality of ventricular anchors extending from a base attached to the expandable frame generally distally before extending generally proximally and radially outwardly from the expandable frame, wherein each of the plurality of ventricular anchors is connected to the expandable frame at the base with a single strut which splits into two struts which connect at the end of the struts to form an atraumatic end;

a first fabric portion covering at least a portion of the ventricular end;

a plurality of second fabric portions each covering at least a portion of each of the plurality of ventricular anchors;

expanding the self-expanding replacement mitral valve prosthesis to an expanded configuration; and

positioning the ventricular anchors so that at least some of the ventricular anchors are located between chordae tendineae;

wherein after the positioning, the ventricular end is located in a left ventricle, the atrial end is located in a left atrium, and the plurality of ventricular anchors are located on a ventricular side of the native mitral valve annulus.

2. The method of claim 1, wherein the self-expanding replacement mitral valve prosthesis provides tension on the chordae tendineae after positioning.

3. The method of claim 1, wherein the expanding comprises releasing the self-expanding replacement mitral valve prosthesis from a delivery system.

4. The method of claim 1, wherein each of the plurality of second fabric portions are attached to the first fabric portion.

5. The method of claim 1, wherein at least some of the plurality of ventricular anchors atraumatically contact tissue.

6. The method of claim 1, wherein the expandable frame comprises a plurality of cells formed by interconnected struts.

7. The method of claim 6, wherein the base of each of the plurality of ventricular anchors is at a location where corners of two adjacent cells meet.

8. The method of claim 6, wherein the base of each of the plurality of ventricular anchors is at a distalmost corner of a cell.

9. The method of claim 6, wherein adjacent looped ends of the plurality of ventricular anchors are spaced apart by at least one cell.

10. The method of claim 1, further comprising a valve body attached to the expandable frame.

11. The method of claim 1, wherein, when the self-expanding replacement mitral valve prosthesis is expanded within the native heart valve, the middle portion engages the native mitral valve annulus.

12. The method of claim 1, wherein the expanding occurs in the native mitral valve annulus.

13. The method of claim 1, wherein the plurality of ventricular anchors are moved proximally towards the left atrium for the positioning.

14. The method of claim 1, wherein the distal end of each of the plurality of ventricular anchors is covered by the plurality of second fabric portions.

15. The method of claim 1, wherein at least some of the plurality of ventricular anchors atraumatically contact tissue on a ventricular side of the native mitral valve annuls and the middle portion engages the native mitral valve annulus after the positioning.

16. The method of claim 1, wherein the two struts form a generally triangular loop.

17. The method of claim 1, wherein the atraumatic end is substantially flat.

18. The method of claim 1, wherein the expandable frame is bulbous and further comprises a transition portion between the middle portion and the distal portion, the transition portion curving inwards from the middle portion, and wherein the ends of each of the plurality of ventricular anchors are longitudinally located distal to the middle portion in the transition portion or the distal portion.

19. The method of claim 1, wherein after the positioning, the ventricular end of the expandable frame curves radially inwards to form a convex curve and each of the plurality of ventricular anchors extends in a radially inward curve to form a convex curve that generally matches the convex curve of the expandable frame.

20. The method of claim 1, wherein after the positioning, the ventricular end of the expandable frame tapers radially inwards and each of the plurality of ventricular anchors extends in a radially inward direction that generally matches the radially inward taper of the expandable frame.