SYSTEMS AND METHODS OF SEALING A DEPLOYED VALVE COMPONENT

• US 20170112620A1
• Filed: 10/12/2016
• Published: 04/27/2017
• Est. Priority Date: 10/22/2015
• Status: Abandoned Application

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Curley, Donna, White, Frank, Anderson, Marc
• Application Number:
  US15/291,909
• Publication Number:
  US 20170112620A1
• Time in Patent Office: 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 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A sealing system for sealing a valve component in a radially expanded deployed configuration includes a valve component and an expandable sealing component. The valve component includes a frame and a prosthetic valve coupled to the frame. The frame defines a central passage with the prosthetic valve disposed therein. The expandable sealing component includes a sealing frame and a skirt coupled to the sealing frame. The expandable sealing component is configured to be inserted in a compressed configuration within the central passage of the valve component with the valve component in the radially expanded deployed configuration. The expandable sealing component is configured to be radially expanded partially within the valve component, with a first portion disposed within the valve component and a second portion disposed longitudinally outside the valve component. The sealing frame may include a first ring and a second ring.

Claims

1. A sealing system comprising:

a valve component including a frame and a prosthetic valve coupled to the frame, the valve component having a radially expanded deployed configuration, an inflow portion and an outflow portion, the frame defining a central passage, the prosthetic valve disposed within the central passage of the frame; and

an expandable sealing component including a sealing frame and a skirt coupled to the frame, the expandable sealing component configured to be inserted in a radially compressed configuration within the central passage with the valve component in the radially expanded deployed configuration, the expandable sealing component further configured to be radially expanded to a radially expanded configuration partially within the valve component such that a first portion of the sealing component is disposed within the valve component and a second portion of the sealing component is disposed longitudinally outside the valve component, the expandable sealing component configured to prevent blood flow radially between the valve component and a wall of the native valve complex.

2. The sealing system of claim 1, wherein the first portion is disposed within the inflow portion of the valve component, the second portion is disposed longitudinally outside the inflow component in an upstream direction, and the expandable sealing component is configured to direct blood flow into the inflow portion of the valve component.

3. The sealing system of claim 1, wherein the first portion includes a first ring, the second portion includes a second ring, a first end of the skirt is coupled to the first ring, and a second end of the skirt is coupled to the second ring.

4. The sealing system of claim 3, wherein the first ring of the expandable sealing component is shaped and configured to extend into spaces between members of the frame of the valve component when the expandable sealing component is in the radially expanded configuration.

5. The sealing system of claim 4, wherein the first ring undulates toward and away from a central longitudinal axis of the sealing component.

6. The sealing system of claim 3, wherein the first ring of the expandable sealing component further comprises a plurality of protrusions, extending radially outwardly.

7. The sealing system of claim 6, wherein the plurality of protrusions of the first ring are configured to couple the first ring of the expandable sealing component to a wall of the valve component when the expandable sealing component is in the radially expanded configuration.

8. The sealing system of claim 3, wherein the second ring of the expandable sealing component comprises a plurality of protrusions extending radially outwardly.

9. The sealing system of claim 8, wherein the plurality of protrusions of the second ring are configured to embed in the wall of the native valve complex when the expandable sealing component is in the radially expanded configuration.

10. The sealing system of claim 1, wherein the expandable sealing component is configured to be retrievable.

11. The sealing system of claim 10, wherein the expandable sealing component is configured to inhibit tissue ingrowth.

12. The sealing system of claim 1, wherein the expandable sealing component is configured to promote tissue ingrowth.

13. The sealing system of claim 1, where in the expandable sealing component is selected from the group consisting of self-expanding, balloon expandable, and mechanically expandable.

14. A method of correcting paravalvular leakage of an installed valvular prosthesis, the valvular prosthesis including a frame and a prosthetic valve coupled to the frame, the method comprising the steps of:

advancing an expandable sealing component in a radially compressed configuration to a location partially within a portion of the frame of the valvular prosthesis with the frame in a radially expanded configuration within a native valve complex, the expandable sealing component including a sealing frame and a skirt coupled to the sealing frame; and

expanding the expandable sealing component to a radially expanded configuration such that the expandable sealing component prevents blood flow radially between the valvular prosthesis and a wall of the native valve complex.

15. The method of claim 14, wherein the step of advancing the expandable sealing component comprises advancing the expandable sealing component to a location such that a first portion of the expandable sealing component is disposed in the inflow portion of the valvular prosthesis, and a second portion of the sealing component is disposed longitudinally outside the inflow portion of the valvular prosthesis in an upstream direction such that the expandable sealing component directs blood flow into the inflow portion.

16. The method of claim 15, wherein the first portion includes a first ring, the second portion includes a second ring, a first end of the skirt is coupled to the first ring, and a second end of the skirt is coupled to the second ring.

17. The method of claim 16, wherein the first ring includes a plurality of protrusions, and wherein the step of expanding the expandable sealing component includes forcing the plurality of protrusions radially outward such that the plurality of protrusions of the first ring engage a wall of the valvular prosthesis.

18. The method of claim 16, wherein the second ring includes a plurality of protrusions, and wherein the step of expanding the expandable sealing component includes forcing the plurality of protrusions radially outward into the native wall of the native valve complex.

19. The method of claim 14, wherein the step of expanding the expandable sealing component is selected from the group consisting of releasing the expandable sealing component such that the expandable sealing component self-expands, inflating a balloon to expand the expandable sealing component, and actuating a mechanical expansion mechanism to expand the expandable sealing component.