Transcatheter valve with paravalvular leak sealing ring

• US 10,028,831 B2
• Filed: 05/04/2017
• Issued: 07/24/2018
• Est. Priority Date: 05/16/2014
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Morin, Kristen T., Para, Andrea N., Braido, Peter N., Khouengboua, Sounthara, Benson, Thomas M., Kumar, Saravana B., Moseman, Bruce, Satam, Gaurav
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/586,595
• Publication Number:
  US 20170231764A1
• Time in Patent Office: 446 Days
• Field of Search: 623 21- 219
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/2472 Devices for testing
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0017 Angular shapes
• CPC Class Codes: A61F 2230/0019 rectangular
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve includes a collapsible and expandable stent extending from an inflow end to an outflow end and a plurality of prosthetic valve leaflets coupled to the stent. The prosthetic heart valve may also include a sealing ring coupled to the inflow end of the stent, the sealing ring comprising a tube extending circumferentially around the inflow end of the stent. The tube may be formed from a wire coiled into a repeating shape, such as a rectangle or a diamond, so that the tube is collapsible. A covering may at least partially surround the tube. The sealing ring may include a first filler positioned within the tube and/or a second filler positioned between the tube and the covering.

Claims

1. A method of delivering a prosthetic heart valve to a patient comprising:

loading the prosthetic heart valve into an outer sheath of a delivery device in a collapsed condition, the prosthetic heart valve including a collapsible and expandable stent extending from an inflow end to an outflow end, a plurality of valve leaflets coupled to the stent, and a sealing ring coupled to the stent adjacent the inflow end, the sealing ring including a tube;

advancing the delivery device to a native valve annulus of the patient; and

fully deploying the prosthetic heart valve from the outer sheath and into the native valve annulus so that the prosthetic heart valve transitions from the collapsed condition to an expanded condition;

wherein the tube has a profile that increases from a reduced profile to an enlarged profile as the prosthetic heart valve transitions from the collapsed condition to the expanded condition.

2. The method of claim 1, wherein the valve leaflets include a leaflet belly and the sealing ring is axially offset from the leaflet belly while the prosthetic heart valve is maintained in the collapsed condition by the outer sheath.

3. The method of claim 2, wherein after the prosthetic valve is fully deployed from the outer sheath, the sealing ring axially overlaps the leaflet belly.

4. The method of claim 1, wherein the tube includes a wire coiled into a repeating shape.

5. The method of claim 4, wherein the wire is formed of a shape-memory alloy.

6. The method of claim 5, wherein the tube has the enlarged profile in the absence of applied forces.

7. The method of claim 4, wherein the wire is coiled into a rectangular shape.

8. The method of claim 4, wherein the wire is coiled into a diamond shape having a major axis and a minor axis.

9. The method of claim 8, wherein the major axis is approximately 3 mm and the minor axis is approximately 2 mm when the prosthetic heart valve is in the expanded condition.

10. The method of claim 1, further comprising the step of partially deploying the prosthetic heart valve from the outer sheath so that the sealing ring has the enlarged profile and is positioned in the native valve annulus, while the outflow end of the stent remains in the outer sheath of the delivery device.

11. The method of claim 10, further comprising testing at least one of a position and a function of the prosthetic heart valve after partially deploying the prosthetic heart valve and prior to fully deploying the prosthetic heart valve.

12. The method of claim 11, further comprising resheathing the prosthetic valve into the outer sheath of the delivery device so that the tube has the reduced profile, after testing the prosthetic heart valve.

13. The method of claim 12, wherein the tube of the sealing ring pivots away from the inflow end of the stent during the resheathing step.

14. The method of claim 1, wherein the tube extends circumferentially around the inflow end of the stent and a covering at least partially surrounds the tube.

15. The method of claim 14, wherein the covering is formed from a material selected form the group consisting of tissues, fabrics, and polymers.

16. The method of claim 14, wherein a first filler is positioned within the tube.

17. The method of claim 16, wherein the first filler is formed from a material selected from the group consisting of metals, tissues, fabrics, polymers, and water-swellable materials.

18. The method of claim 17, wherein, following full deployment of the prosthetic valve from the outer sheath, the first filler expands upon exposure to blood.

19. The method of claim 16, wherein a second filler is positioned between the tube and the covering.

20. The method of claim 14, wherein a first filler is positioned between the tube and the covering.