Method of Treating Paravalvular Leakage After Prosthetic Valve Implantation

• US 20140194975A1
• Filed: 01/08/2013
• Published: 07/10/2014
• Est. Priority Date: 01/08/2013
• Status: Active Grant

• Current Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Inventors: Quill, Jason, Rothstein, Paul
• Granted Patent: US 8,986,371 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A method for treating paravalvular leakage at a location of a stented prosthetic valve includes the steps of delivering a clip to a location adjacent chordae tendinae of a native valve, and deploying the clip such that the clip captures at least some of the chordae tendinae of the native valve, thereby increasing tension in the captured chordae tendinae. The clip is delivered to the location in a collapsed stated and is released from a sheath convert to an undeflected or relaxed state. After the clip is released from the sheath, the clip is rotated to capture the chordae tendinae. The clip is then released from the delivery system and the delivery system is retracted.

Claims

1. A method for treating paravalvular leakage at a location of a prosthetic valve comprising the steps of:

delivering a clip to a location adjacent chordae tendinae of a native valve; and

deploying the clip such that the clip captures at least some of the chordae tendinae of the native valve, thereby increasing tension in the captured chordae tendinae.

2. The method of claim 1, wherein the step of deploying the clip comprises releasing the clip from a sheath such that the clip converts from a collapsed state to an undeflected state.

3. The method of claim 2, wherein the step of releasing the clip from the sheath comprises retracting the sheath relative to the clip.

4. The method of claim 2, wherein the step of deploying the clip further comprises rotating the clip in the undeflected state adjacent the chordate such that the clip captures at least some of the chordae tendinae as the clip is being rotated.

5. The method of claim 4, wherein the step of deploying the clip further comprises releasing the clip from a delivery device.

6. The method of claim 1, wherein the prosthetic valve comprises:

a stent frame;

support arms extending from a distal portion of the stent frame and bent backwards such that leaflets of the native valve are disposed between the support arms and an outer surface of the stent frame; and

a prosthetic valve component.

7. The method of claim 1, wherein the native valve is the mitral valve.

8. The method of claim 1, further comprising the steps of;

delivering a second clip to a location adjacent the chordae tendinae of the native valve; and

deploying the second clip such that the second clip captures at least some of the chordate tendinae of the native valve, thereby increasing tension in the capture chordae tendinae.

9. The method of claim 8, wherein the clip captures the chordae tendinae coupled to one leaflet of the native valve and wherein the second clip captures the chordae tendinae coupled to a different leaflet of the native valve.

10. The method of claim 8, wherein both the clip and the second clip capture the chordae tendinae coupled to the same leaflet of the native valve.

11. The method of claim 1, further comprising the step of detecting paravalvular leakage around the prosthetic valve prior to the steps of delivering and deploying the clip.

12. A method of implanting a prosthetic valve and treating paravalvular leakage comprising the steps of:

tracking a prosthetic valve delivery system to the native mitral valve in a radially compressed configuration for delivery;

deploying the prosthetic valve at the native mitral valve;

detecting paravalvular leakage at the prosthetic valve implantation site;

delivering a clip to a location adjacent chordae tendinae of the native mitral valve; and

deploying the clip such that the clip captures at least some of the chordae tendinae of the native mitral valve, thereby increasing tension in the captured chordae tendinae.

13. The method of claim 12, wherein the wherein the prosthetic valve delivery system includes a valve prosthesis having a tubular stent, a prosthetic valve component disposed within and secured to the stent, and at least two support arms coupled to and distally extending from a distal end of the stent when the stent is in the radially compressed configuration.

14. The method of claim 13, wherein the step of deploying the prosthetic valve comprises:

retracting an outer sheath of the prosthetic valve delivery system to expose the support arms, wherein each support arm bends radially outward and then towards an outer surface of the stent; and

further retracting the outer sheath to expose the stent, thereby allowing the stent to self-expand into the deployed configuration.

15. The method of claim 12, wherein the step of detecting paravalvular leakage is selected from the methods consisting of intravascular ultrasound, transesophageal echocardiography, and intracardiac echocardiography.

16. The method of claim 12, wherein the step of deploying the clip comprises releasing the clip from a sheath such that the clip converts from a collapsed state to an undeflected state.

17. The method of claim 16, wherein the step of releasing the clip from the sheath comprises retracting the sheath relative to the clip.

18. The method of claim 16, wherein the step of deploying the clip further comprises rotating the clip in the undeflected state adjacent the chordate such that the clip captures at least some of the chordae tendinae as the clip is being rotated.

19. The method of claim 18, wherein the step of deploying the clip further comprises releasing the clip from a delivery device.

20. The method of claim 12, further comprising the steps of;

delivering a second clip to a location adjacent the chordae tendinae of the native valve; and

deploying the second clip such that the second clip captures at least some of the chordate tendinae of the native valve, thereby increasing tension in the capture chordae tendinae.

21. The method of claim 20, wherein the clip captures the chordae tendinae coupled to one leaflet of the native valve and wherein the second clip captures the chordae tendinae coupled to a different leaflet of the native valve.

22. The method of claim 20, wherein both the clip and the second clip capture the chordae tendinae coupled to the same leaflet of the native valve.