Systems and methods for anchoring and sealing a prosthetic heart valve

• US 10,092,400 B2
• Filed: 06/23/2016
• Issued: 10/09/2018
• Est. Priority Date: 06/23/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Jimenez, Jorge H., Greene, James L.
• Primary Examiner(s): DUKERT, BRIAN AINSLEY
• Application Number:
  US15/191,054
• Publication Number:
  US 20160374801A1
• Time in Patent Office: 838 Days
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility

Abstract

Embodiments of the present disclosure provide a prosthetic heart valve. The prosthetic heart valve includes an outer frame, an inner frame positioned at least partially within the outer frame, and an occluder member positioned at least partially within the inner frame. The prosthetic heart valve also includes an atrial flange extending from an atrial end of the outer frame, and a ventricular flange extending from a ventricular end of the outer frame, wherein at least a portion of the atrial flange extends radially outward beyond the ventricular flange.

Claims

1. A prosthetic heart valve comprising:

an outer frame;

one or more actuator members coupled to the outer frame, wherein the actuator members are configured to facilitate movement of the outer frame between a collapsed state and a expanded state;

an inner frame positioned at least partially within the outer frame;

an occluder member positioned at least partially within the inner frame;

an atrial flange extending from an atrial end of the outer frame; and

a ventricular flange extending from a ventricular end of the outer frame;

wherein at least a portion of the atrial flange extends radially outward beyond the ventricular flange.

2. The prosthetic heart valve of claim 1, wherein the outer frame comprises an expandable outer frame, and wherein the inner frame comprises an expandable inner frame.

3. The prosthetic heart valve of claim 2, wherein the outer frame is configured for reversibly moving between the collapsed state and the expanded state, and wherein the inner frame is configured for deforming between a collapsed state and an expanded state.

4. The prosthetic heart valve of claim 1, wherein in the expanded state the outer frame has a first cross-sectional shape in a plane orthogonal to a longitudinal axis of the prosthetic heart valve, wherein in an expanded state the inner frame has a second cross-sectional shape in the plane orthogonal to the longitudinal axis of the prosthetic heart valve, and wherein the first cross-sectional shape is different than the second cross-sectional shape.

5. The prosthetic heart valve of claim 1, wherein in the expanded state the outer frame has a D-shaped cross-sectional shape in a plane orthogonal to a longitudinal axis of the prosthetic heart valve, and wherein in an expanded state the inner frame has a circular cross-sectional shape in the plane orthogonal to the longitudinal axis of the prosthetic heart valve.

6. The prosthetic heart valve of claim 1, wherein the inner frame is attached to the outer frame.

7. The prosthetic heart valve of claim 1, further comprising a trampoline attached to the outer frame and the inner frame and extending therebetween, wherein the trampoline transfers forces from the outer frame to the inner frame such that when the one or more actuator members are actuated to expand or collapse the outer frame, the inner frame is caused to expand or collapse along with the outer frame.

8. The prosthetic heart valve of claim 1, wherein the atrial flange comprises a plurality of deflectable petals configured to move between a collapsed state and an expanded state.

9. The prosthetic heart valve of claim 8, wherein the plurality of deflectable petals comprises a first petal having a first length and a second petal having a second length, wherein the first length is different than the second length.

10. The prosthetic heart valve of claim 8, wherein the plurality of deflectable petals comprises a first petal having a first stiffness and a second petal having a second stiffness, wherein the first stiffness is different than the second stiffness.

11. The prosthetic heart valve of claim 1, wherein the ventricular flange comprises a plurality of deflectable petals configured to move between a collapsed state and an expanded state.

12. The prosthetic heart valve of claim 11, wherein the plurality of deflectable petals comprises a first petal having a first length and a second petal having a second length, wherein the first length is different than the second length.

13. The prosthetic heart valve of claim 11, wherein the plurality of deflectable petals comprises a first petal having a first stiffness and a second petal having a second stiffness, wherein the first stiffness is different than the second stiffness.

14. The prosthetic heart valve of claim 1, wherein the entire atrial flange extends radially outward beyond the ventricular flange.

15. The prosthetic heart valve of claim 1, further comprising a covering formed of a biocompatible cloth or textile material, wherein the covering extends over the outer frame and at least a portion of the atrial flange or the ventricular flange.

16. The prosthetic heart valve of claim 1, wherein the occluder member comprises a multi-leaflet valve attached to the inner frame.

21. The prosthetic heart valve of claim 1, wherein the actuator members are configured to controllably expand and controllably collapse the outer frame to a plurality of intermediate states between the collapsed state and the expanded state.

22. The prosthetic heart valve of claim 7, wherein the trampoline comprises a plurality of frame members connected to and extending radially between the outer frame and the inner frame.

17. A prosthetic heart valve comprising:

an outer frame having one or more actuator members configured to facilitate movement of the prosthetic heart valve between a collapsed state and an expanded state, wherein the outer frame has a D-shaped cross-sectional shape in a plane orthogonal to a longitudinal axis of the prosthetic heart valve when the prosthetic heart valve is in the expanded state;

an inner frame positioned at least partially within the outer frame and having a circular cross-sectional shape in the plane orthogonal to the longitudinal axis of the prosthetic heart valve when the prosthetic heart valve is in the expanded state;

an occluder member positioned at least partially within the inner frame;

an atrial flange extending from an atrial end of the outer frame;

a ventricular flange extending from a ventricular end of the outer frame; and

a plurality of intermediate frame members connected to and extending radially between the outer frame and the inner frame, wherein the intermediate frame members transfer forces from the outer frame to the inner frame such that when the one or more actuator members are actuated to expand or collapse the outer frame, the inner frame expands or collapses along with the outer frame.

18. The prosthetic heart valve of claim 17, wherein the atrial flange comprises a plurality of deflectable petals configured to move between a collapsed state and an expanded state, and wherein the ventricular flange comprises a plurality of deflectable petals configured to move between a collapsed state and an expanded state, and wherein at least one of the petals of the atrial flange has a different length or a different stiffness than at least one of the petals of the ventricular flange.

19. A prosthetic heart valve comprising:

an expandable outer frame having a plurality of wire members and a mechanical element attached to the wire members, wherein the mechanical element is configured such that movement of the mechanical element relative to the wire members moves the prosthetic heart valve between a radially-collapsed state and a radially-expanded state, wherein the outer frame has a D-shaped cross-sectional shape in a plane orthogonal to a longitudinal axis of the prosthetic heart valve when the prosthetic heart valve is in the radially-expanded state;

an expandable inner frame positioned at least partially within the outer frame and having a circular cross-sectional shape in the plane orthogonal to the longitudinal axis of the prosthetic heart valve when the prosthetic heart valve is in the radially-expanded state;

an occluder member positioned at least partially within the inner frame;

an atrial flange extending from an atrial end of the outer frame; and

a ventricular flange extending form a ventricular end of the outer frame;

wherein at least a portion of the atrial flange extends radially outward beyond the ventricular flange.

20. The prosthetic heart valve of claim 19, wherein the mechanical element comprises a threaded rod configured to be received within a threaded tube that is coupled to the wire members.