Valve prosthesis having a radially-expandable sleeve integrated thereon for delivery and prevention of paravalvular leakage

• US 10,433,993 B2
• Filed: 01/20/2017
• Issued: 10/08/2019
• Est. Priority Date: 01/20/2017
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Rothstein, Paul
• Primary Examiner(s): Holwerda, Kathleen S
• Assistant Examiner(s): Byrd, Brigid K
• Application Number:
  US15/411,494
• Publication Number:
  US 20180207011A1
• Time in Patent Office: 991 Days
• Field of Search: 623 115, 623 117, 623 12, 623 13, 623 211
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2210/0057 stretchable
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

A delivery system includes an elongated shaft component, a self-expanding valve prosthesis, at least one cinching suture, and a radially-expandable sleeve. The valve prosthesis is disposed over a distal portion of the elongated shaft component and includes a compressed configuration for delivery and an expanded configuration for deployment. The at least one cinching suture removably couples the valve prosthesis to the elongated shaft component and radially compresses the valve prosthesis into the compressed configuration for delivery. The sleeve is secured to and encircles an outer surface of the valve prosthesis. The sleeve has a delivery state with a first diameter extending over a full length of the valve prosthesis in the compressed configuration and a deployed state with a greater second diameter extending over the full length of the valve prosthesis in the expanded configuration. The sleeve is configured to prevent paravalvular leakage in situ in the deployed state.

Claims

1. A delivery system for percutaneously delivering a self-expanding valve prosthesis comprising:

an elongated shaft component;

a self-expanding valve prosthesis disposed over a distal portion of the elongated shaft component, wherein the valve prosthesis has a compressed configuration for delivery within a vasculature and an expanded configuration for deployment;

at least one cinching suture for coupling the valve prosthesis to the elongated shaft component, wherein the at least one cinching suture is removable and radially compresses the valve prosthesis into the compressed configuration for delivery; and

a radially-expandable sleeve secured to and encircling an outer surface of the valve prosthesis, wherein the radially-expandable sleeve is configured to transform from a delivery state in which the radially-expandable sleeve has a first diameter and extends over a full length of the valve prosthesis in the compressed configuration to a deployed state in which the radially-expandable sleeve has a second diameter greater than the first diameter and extends over a portion of the valve prosthesis in the expanded configuration, the portion being less than the full length of the valve prosthesis, the radially-expandable sleeve being configured to prevent paravalvular leakage in situ in the deployed state.

2. The delivery system of claim 1, wherein the radially-expandable sleeve contracts longitudinally when the radially-expandable sleeve transforms from the delivery state to the deployed state such that the radially-expandable sleeve in the deployed state extends over only an inflow end portion of the valve prosthesis in the expanded configuration and lays flush against the outer surface of the valve prosthesis.

3. The delivery system of claim 2, wherein the radially-expandable sleeve is formed from an elastic material that is stretched over the valve prosthesis in the compressed configuration.

4. The delivery system of claim 3, further comprising at least one sleeve-restraining suture for coupling the radially-expandable sleeve to the delivery system, wherein the at least one sleeve-restraining suture is removable.

5. The delivery system of claim 4, wherein the at least one cinching suture is disposed between the outer surface of the valve prosthesis and an inner surface of the radially-expandable sleeve.

6. The delivery system of claim 4, wherein the at least one sleeve-restraining suture includes a first sleeve-restraining suture at a first end of the radially-expandable sleeve and a second sleeve-restraining suture at a second end of the radially-expandable sleeve.

7. The delivery system of claim 1, wherein the radially-expandable sleeve is secured to the outer surface of the valve prosthesis via at least one sleeve-anchoring suture.

8. The delivery system of claim 1, wherein the valve prosthesis includes a tubular stent and a prosthetic valve component disposed within and secured to the stent.

9. A delivery system for percutaneously delivering a self-expanding valve prosthesis comprising:

an elongated shaft component;

a self-expanding valve prosthesis disposed over a distal portion of the elongated shaft component, wherein the valve prosthesis has a compressed configuration for delivery within a vasculature and an expanded configuration for deployment;

at least one cinching suture for coupling the valve prosthesis to the elongated shaft component, wherein the at least one cinching suture is removable and radially compresses the valve prosthesis into the compressed configuration for delivery; and

a radially-expandable sleeve secured to and encircling an outer surface of the valve prosthesis, wherein the radially-expandable sleeve is configured to transform from a delivery state in which the radially-expandable sleeve has a first diameter and extends over a full length of the valve prosthesis in the compressed configuration and forms an outermost component of the delivery system for a longitudinal portion thereof to a deployed state in which the radially-expandable sleeve has a second diameter greater than the first diameter and extends over a portion of the valve prosthesis in the expanded configuration, the portion being less than the full length of the valve prosthesis, the radially-expandable sleeve being configured to prevent paravalvular leakage in situ in the deployed state.

10. The delivery system of claim 9, wherein the radially-expandable sleeve contracts longitudinally when the radially-expandable sleeve transforms from the delivery state to the deployed state such that the radially-expandable sleeve in the deployed state extends over only an inflow end portion of the valve prosthesis in the expanded configuration and lays flush against the outer surface of the valve prosthesis.

11. The delivery system of claim 10, wherein the radially-expandable sleeve is formed from an elastic material that is stretched over the valve prosthesis in the compressed configuration.

12. A delivery system for percutaneously delivering a self-expanding valve prosthesis comprising:

an elongated shaft component;

a self-expanding valve prosthesis disposed over a distal portion of the elongated shaft component, wherein the valve prosthesis has a compressed configuration for delivery within a vasculature and an expanded configuration for deployment;

at least one cinching suture for coupling the valve prosthesis to the elongated shaft component, wherein the at least one cinching suture is removable and radially compresses the valve prosthesis into the compressed configuration for delivery; and

a radially-expandable sleeve secured to and encircling an outer surface of the valve prosthesis, wherein the radially-expandable sleeve has a delivery state in which the radially-expandable sleeve has a first diameter and extends over a full length of the valve prosthesis in the compressed configuration and a deployed state in which the radially-expandable sleeve has a second diameter greater than the first diameter and extends over a portion of the valve prosthesis in the expanded configuration, the portion being less than the full length of the valve prosthesis, the radially-expandable sleeve being configured to prevent paravalvular leakage in situ in the deployed state,

wherein the radially-expandable sleeve is configured to contract longitudinally when the radially-expandable sleeve transforms from the delivery state to the deployed state.

13. The delivery system of claim 12, wherein the radially-expandable sleeve in the deployed state extends over only an inflow end portion of the valve prosthesis in the expanded configuration and lays flush against the outer surface of the valve prosthesis.

14. The delivery system of claim 12, wherein the radially-expandable sleeve is formed from an elastic material that is stretched over the valve prosthesis in the compressed configuration.

15. The delivery system of claim 12, further comprising at least one sleeve-restraining suture for coupling the radially-expandable sleeve to the delivery system, wherein the at least one sleeve-restraining suture is removable.

16. The delivery system of claim 15, wherein the at least one cinching suture is disposed between the outer surface of the valve prosthesis and an inner surface of the radially-expandable sleeve.

17. The delivery system of claim 15, wherein the at least one sleeve-restraining suture includes a first sleeve-restraining suture at a first end of the radially-expandable sleeve and a second sleeve-restraining suture at a second end of the radially-expandable sleeve.