Paravalvular sealing via extended cuff mechanisms

• US 10,143,551 B2
• Filed: 01/14/2015
• Issued: 12/04/2018
• Est. Priority Date: 03/31/2014
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N., Alkhatib, Yousef F., Anderl, Steven Frederick, Daly, Jacob John, Fahim, Mina S., Smith, Kent J., Thomas, Ralph J.
• Primary Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US15/128,909
• Publication Number:
  US 20170189174A1
• Time in Patent Office: 1,420 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve 300 may include a collapsible and expandable stent 306 having a proximal end 302, a distal end 304, an annulus section adjacent the proximal end, and a plurality of cells connected to one another in annular rows around the stent, a cuff 312 attached to the stent, and a sealing member 322 attached to the cuff and extending from a proximal end 313 of the cuff to a free edge 323. The sealing member 322 may be movable between an extended condition in which the free edge 323 is located proximally of the proximal end 302 of the stent 306, and an inverted condition in which the free edge is located distally of the proximal end of the stent and a first surface 324 of the sealing member confronts an outward-facing surface of the cuff. Various mechanisms for moving the sealing member 322 are also described.

Claims

1. A prosthetic heart valve configured to be expanded proximate a native valve of a patient, the prosthetic heart valve comprising:

a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end, and a plurality of cells connected to one another in a plurality of annular rows around the stent, the stent having a flow direction extending from the proximal end of the stent toward the distal end of the stent;

a cuff attached to the annulus section of the stent and defining an outward-facing surface;

a plurality of prosthetic valve leaflets attached to the cuff;

a sealing member attached to the cuff and extending from a proximal end of the cuff to a free edge, the sealing member being movable between an extended condition in which the free edge is located proximally of the proximal end of the stent, and an inverted condition in which the free edge is located distally of the proximal end of the stent and a first surface of the sealing member confronts the outward-facing surface of the cuff; and

a sealing ring attached to a second surface of the sealing member opposite the first surface, wherein in the inverted condition of the sealing member and in an expanded use condition of the stent, the sealing ring has a diameter greater than a diameter of the proximal end of the stent.

2. The prosthetic heart valve of claim 1, wherein the sealing member in the extended condition is located entirely below the proximal end of the stent.

3. The prosthetic heart valve of claim 1, wherein the sealing member in the inverted condition extends continuously around a circumference of the stent.

4. The prosthetic heart valve of claim 1, wherein in the extended condition of the sealing member, the sealing ring is located entirely proximally of the proximal end of the stent.

5. The prosthetic heart valve of claim 1, further comprising:

a stored energy element inside the sealing ring, wherein in the inverted condition of the sealing member the stored energy element is biased to provide a force to an outer edge of the sealing ring in a direction orthogonal to the flow direction when the outer edge is radially compressed.

6. The prosthetic heart valve of claim 5, wherein the stored energy element includes a spring that extends in at least one complete loop about a circumference of the sealing ring.

7. The prosthetic heart valve of claim 1, further comprising:

a plurality of retractable wires extending between a first position on the stent and a second position near the free edge of the sealing member, the retractable wires having a first length in the extended condition of the sealing member and a second length in the inverted condition of the sealing member, the second length being shorter than the first length.

8. A prosthetic heart valve configured to be expanded proximate a native valve of a patient, the prosthetic heart valve comprising:

a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end, and a plurality of cells connected to one another in a plurality of annular rows around the stent, the stent having a flow direction extending from the proximal end of the stent toward the distal end of the stent;

a cuff attached to the annulus section of the stent and defining an outward-facing surface;

a plurality of prosthetic valve leaflets attached to the cuff; and

a sealing member attached to the cuff and extending from a proximal end of the cuff to a free edge, the sealing member being configured to move between an extended condition in which the free edge is located a first distance proximally of the proximal end of the stent, and a compressed condition in which the free edge is located a second distance proximally of the proximal end of the stent.

9. The prosthetic heart valve of claim 8, wherein in the compressed condition of the sealing member and in an expanded use condition of the stent, the sealing member has a diameter greater than a diameter of the proximal end of the stent.

10. The prosthetic heart valve of claim 8, wherein in the compressed condition of the sealing member and in an expanded use condition of the stent, the sealing member has a plurality of alternating peaks and valleys extending in the circumferential direction of the stent, the peaks being located at a greater radial distance away from the stent than the valleys.

11. The prosthetic heart valve of claim 10, wherein in the compressed condition of the sealing member and in the expanded use condition of the stent, each of the peaks has an adjacent valley proximal to at least a portion of the respective peak, and each of the peaks has a central portion that extends proximally of the respective adjacent valley.

12. A method of expanding a prosthetic heart valve proximate a native valve of a patient, the prosthetic heart valve including a stent having proximal and distal ends, a cuff attached to the stent, a sealing member extending from a proximal end of the cuff to a free edge and having a first surface, and a sealing ring attached to a second surface of the sealing member opposite the first surface, the method comprising:

collapsing the prosthetic heart valve into a delivery device such that the sealing member is in an extended condition in which the free edge is located proximally of the proximal end of the stent;

inserting the delivery device into a patient;

advancing the delivery device proximate an annulus of the native valve;

partially expanding the prosthetic heart valve in a selected position proximate the native valve;

moving the sealing member from the extended condition to an inverted condition in which the free edge is located distally of the proximal end of the stent and the first surface of the sealing member confronts an outward-facing surface of the cuff, wherein the moving step includes inverting the sealing ring from an inward-facing condition to an outward facing condition in which the sealing ring has a diameter greater than a diameter of the proximal end of the stent; and

fully expanding the prosthetic heart valve.

13. The method of claim 12, wherein the sealing member in the extended condition is located entirely proximally of the proximal end of the stent.

14. The method of claim 12, wherein the sealing member includes wires extending from the free end of the sealing member through the delivery device to a location outside the patient, and the moving step includes pulling the wires to move the free edge of the sealing member.

15. The method of claim 14, further comprising:

withdrawing the wires from the patient while leaving the prosthetic heart valve inside the patient.

16. The method of claim 15, wherein in the extended condition of the sealing member, the sealing ring is located entirely proximally of the proximal end of the stent.

17. The method of claim 12, wherein the sealing member includes wires extending between a first position on the stent and a second position near the free edge of the sealing member, the collapsing step includes extending the wires to a first length, and the moving step includes contracting the wires to a second length shorter than the first length.