Prosthetic valve for replacing a mitral valve

• US 10,010,414 B2
• Filed: 12/16/2016
• Issued: 07/03/2018
• Est. Priority Date: 06/06/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Cooper, Alexander H., Peterson, Matthew A., Brunnett, William C.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US15/382,429
• Publication Number:
  US 20170095328A1
• Time in Patent Office: 564 Days
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

Embodiments of a prosthetic heart valve comprise an annular main body, an atrial cap extending radially outwardly from the atrial end of the main body, and a plurality of ventricular anchors extending outwardly from the ventricular end of the main body. Each ventricular anchor can have a proximal end portion connected to the ventricular end, an intermediate portion extending away from the atrial end and then back toward the atrial so as to define a first bend, and a free distal end portion that extends from the intermediate portion. The distal end portion can comprise a first section, a second section, and a second bend between the first and second sections, the first section extending from the intermediate portion in a direction toward the atrial end and radially away from the main body.

Claims

1. A method of implanting a prosthetic heart valve at a native atrioventricular valve region having a native valve annulus and a plurality of native leaflets, comprising:

delivering a prosthetic heart valve to a native valve region, the prosthetic heart valve contained within an interior of a sheath of a delivery apparatus, the prosthetic heart valve comprising an annular main body having an atrial end, a ventricular end and a longitudinal axis extending from the atrial end to the ventricular end, an atrial portion extending from the main body, and a plurality of ventricular anchors extending from the main body, each ventricular anchor being connected to the main body at only one location on the main body; and

deploying the prosthetic heart valve from the sheath such that main body expands within the native annulus, the atrial portion is deployed in an atrium adjacent the native annulus, and the plurality of ventricular anchors extend behind the native leaflets, each ventricular anchor having a proximal end portion connected to and extending from the main body, an intermediate portion extending toward the atrial end of the main body, and a distal end portion extending from the intermediate portion, the distal end portion comprising a tissue-engaging surface that contacts the native leaflets and/or the native annulus and is wider along the tissue-engaging surface than the proximal end portion and the intermediate portion, wherein each of the distal end portions comprises a downstream-facing surface opposite the tissue-engaging surface, the downstream-facing surface and the tissue-engaging surface forming opposite sides of a widened section of the distal end portion having a width that is greater than a width of the proximal end portion and the intermediate end portion, wherein the distal end portions extend generally perpendicular to the longitudinal axis.

2. The method of claim 1, wherein the native valve annulus is the mitral valve annulus and the prosthetic heart valve is delivered to the annulus via the left atrium.

3. The method of claim 1, wherein following deployment, the prosthetic heart valve and the native valve annulus move in a generally synchronous manner during cardiac cycling.

4. The method of claim 1, wherein the atrial portion comprises an atrial sealing cap, which after being deployed, blocks the flow of blood between the native leaflets and the outside of the main body.

5. The prosthetic device of claim 4, wherein the atrial sealing cap comprises a plurality of atrial anchors spaced angularly around a circumference of the main body, each atrial anchor having a proximal end portion connected to the atrial end of the main body and a free distal end portion.

6. The method of claim 1, wherein the main body is a double-body structure comprising an annular inner frame portion and an annular outer frame portion overlapping the inner frame portion, the ventricular anchors extending from one of the inner and outer frame portions and the atrial portion extending from the other of the inner and outer frame portions, the outer frame portion being more flexible than the inner frame portion.

7. The method of claim 6, wherein the ventricular anchors extend from the inner frame portion.

8. The method of claim 6, wherein the inner frame portion and the outer frame portion are connected to each other with sutures.

9. The method of claim 1, wherein the ventricular anchors are connected to the main body independently of each other without frame segments interconnecting adjacent anchors.

10. The method of claim 1, wherein the distal end portion of each ventricular anchor has an opening located between side edges thereof.

11. The method of claim 10, wherein the opening has a tear-drop shape.

12. The method of claim 1, wherein the distal end portion of each ventricular anchor comprises a first section and a second section, the first section extending from the intermediate portion alongside the main body between the atrial end and the ventricular end in a direction toward the atrial end and radially away from the main body at a first angle relative to the longitudinal axis of the main body starting at the intermediate portion and moving toward the second section of the distal end portion, the second section extending from the first section in a direction radially away from the main body at a second angle relative to the longitudinal axis starting at the first section and moving toward a distal end of the second section, the second angle being greater than the first angle.

13. The method of claim 1, wherein for each ventricular anchor, the location where the proximal end portion is connected to the main body is the only location where the ventricular anchor is fixed to the main body.

14. A method of implanting a prosthetic heart valve at a native atrioventricular valve region having a native valve annulus and a plurality of native leaflets, comprising:

delivering a prosthetic heart valve to a native valve region, the prosthetic heart valve contained within an interior of a sheath of a delivery apparatus, the prosthetic heart valve comprising an annular main body having an atrial end, a ventricular end, and a longitudinal axis extending from the atrial end to the ventricular end, the prosthetic heart valve further comprising an atrial portion extending from the main body, and a plurality of ventricular anchors extending from the main body; and

deploying the prosthetic heart valve from the sheath such that main body expands within the native annulus, the atrial portion is deployed in an atrium adjacent the native annulus, and the plurality of ventricular anchors extend behind the native leaflets, each ventricular anchor having a proximal end portion connected to and extending from the main body, an intermediate portion extending from the proximal end portion toward the atrial end of the main body, and a distal end portion extending from the intermediate portion, the distal end portion comprising a first section and a second section, the first section extending from the intermediate portion alongside the main body between the atrial end and the ventricular end in a direction toward the atrial end and radially away from the main body at a first angle relative to the longitudinal axis starting at the intermediate portion and moving toward the second section of the distal end portion, the second section extending from the first section in a direction radially away from the main body at a second angle relative to the longitudinal axis starting at the first section and moving toward a distal end of the second section, the second angle being greater than the first angle and measured in the same direction from the longitudinal axis as the first angle, the second section comprising a tissue-engaging surface facing the atrial end that can contact the native annulus and/or the native leaflets.

15. The method of claim 14, wherein the plurality of ventricular anchors are radially compressible to a radially compressed state for delivery into the heart, wherein each anchor is linearly extended in the radially compressed state, such that the proximal end portions and distal end portions are axially aligned, parallel to the axis of the main body.

16. The method of claim 14, wherein each of the second sections have curved side edges that extend away from each other and then back toward each other moving in a direction toward the distal end of the ventricular anchor such that the width of the second section in the circumferential direction varies along the length of the second section.

17. The method of claim 16, wherein each of the second sections has an opening located between the side edges.

18. The method of claim 14, wherein the second sections of the distal end portions curve toward the atrial end and back toward the ventricular end starting at the first sections and moving toward the distal ends of the second sections.

19. A method of implanting a prosthetic heart valve at a native atrioventricular valve region having a native valve annulus and a plurality of native leaflets, comprising:

delivering a prosthetic heart valve to a native valve region, the prosthetic heart valve contained within an interior of a sheath of a delivery apparatus, the prosthetic heart valve comprising an annular main body having an atrial end, a ventricular end, and a longitudinal axis extending from the atrial end to the ventricular end, the prosthetic heart valve further comprising an atrial portion extending from the main body, and a plurality of ventricular anchors extending from the main body; and

deploying the prosthetic heart valve from the sheath such that main body expands within the native annulus, the atrial portion is deployed in an atrium adjacent the native annulus, and the plurality of ventricular anchors extend behind the native leaflets, each ventricular anchor having a proximal end portion connected to and extending from the main body, an intermediate portion extending from the proximal end portion toward the atrial end of the main body, and a distal end portion extending from the intermediate portion, the distal end portion comprising a tissue-engaging surface that can contact the native annulus and/or the native leaflets, wherein a portion of the tissue engaging surface proximal to a terminal end of the anchor faces in a direction parallel to the longitudinal axis, wherein each ventricular anchor has a length extending along the proximal end portion, the intermediate end portion and the distal end portion, and the distal end portion extends generally perpendicular to the longitudinal axis along the length.

20. The method of claim 19, wherein there are twelve ventricular anchors.

21. The method of claim 19, wherein for each ventricular anchor, the location where the proximal end portion is connected to the main body is the only location where the ventricular anchor is fixed to the main body.