# US 2014/0194975 A1 · Method of Treating Paravalvular Leakage After Prosthetic Valve Implantation

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- Number: US 2014/0194975 A1
- Document ID: US20140194975A1
- Status: Published application
- Kind: A1
- Application number: 13/736,592
- Filed: 2013-01-08
- Published: 2014-07-10
- Earliest claimed: 2013-01-08
- Assignees: Medtronic Cv Luxembourg S.A.R.L.
- Applicants: Medronic Cv Luxembourg S.A.R.L.
- Inventors: Jason Quill; Paul Rothstein
- Web page: https://patentgrep.com/patent/US20140194975A1

## CPC

- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61B 17/1227: {Spring clips}
- A61B 17/1285: {for minimally invasive surgery}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61B 2017/00243: {cardiac}
- A61B 2017/0409: {Instruments for applying suture anchors}
- A61B 2017/0437: {the barbs being resilient or spring-like}
- A61B 2017/0441: {the shaft being a rigid coil or spiral}
- A61B 2017/0464: {for soft tissue}
- A61B 2017/0496: {for tensioning sutures}
- A61F 2/2457: {Chordae tendineae prostheses}
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2230/005: Rosette-shaped, e.g. star-shaped
- A61F 2230/0054: V-shaped
- A61F 2230/008: paraboloidal
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 2)

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

### Claim 4 (depends on 2)

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.

### Claim 5 (depends on 4)

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

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 1)

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

### Claim 8 (depends on 1)

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.

### Claim 9 (depends on 8)

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.

### Claim 10 (depends on 8)

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.

### Claim 11 (depends on 1)

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.

### Claim 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.

### Claim 13 (depends on 12)

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.

### Claim 14 (depends on 13)

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.

### Claim 15 (depends on 12)

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.

### Claim 16 (depends on 12)

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.

### Claim 17 (depends on 16)

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

### Claim 18 (depends on 16)

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.

### Claim 19 (depends on 18)

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

### Claim 20 (depends on 12)

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.

### Claim 21 (depends on 20)

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.

### Claim 22 (depends on 20)

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.
