Devices and methods for addressing valve leaflet problems

Patent metadata

Field	Value
Publication number	US-2024148507-A1
Application number	US-202418413618-A
Country	US
Kind code	A1
Filing date	Jan 16, 2024
Priority date	Jul 16, 2021
Publication date	May 9, 2024
Grant date	—

Abstract

Valvular regurgitation is addressed by implanting devices at or near a native valve to treat leaflet issues. This can be done by treating the leaflets and/or by treating one or more natural chordae tendineae (chords). Treating the leaflets can include methods and devices that bring different leaflets together, and/or inhibiting or arresting a leaflet from billowing and/or flailing into the atrium. Treating the chords can include methods and devices that shorten chords, that increase tension in the chords, that attach chords to the ventricle wall or to each other, and the like. In each of the disclosed methods and devices, coaptation is increased and/or valvular regurgitation is reduced. The disclosed devices and methods can be performed on a beating heart.

First claim

What is claimed is:

1 . A device for treating a native valve, the device comprising:
a first free-edge clipping implant configured to attach to a free edge of a first leaflet; a second free-edge clipping implant configured to attach to a free edge of a second leaflet; a cinching mechanism configured to pull the first free-edge clipping implant and second free-edge clipping implant toward the cinching mechanism; and one or more sutures joining the first free-edge clipping implant and the second free-edge clipping implant to the cinching mechanism, wherein activation of the cinching mechanism tensions the one or more sutures to reduce a distance between the first and second free-edge clipping implants to approximate the second leaflet and the first leaflet to reduce valvular regurgitation.

2 . The device of claim 1 , wherein the cinching mechanism comprises a spooling component configured to adjust tension on the one or more sutures to lengthen and shorten the one or more sutures relative to the cinching mechanism.

3 . The device of claim 2 , wherein the spooling component includes a wheel that is configured to rotate to spool the one or more sutures within or around the spooling component.

4 . The device of claim 2 , wherein the cinching mechanism comprises a locking component configured to lock the first free-edge clipping implant and the second free-edge clipping implant in place or to lock the one or more sutures in place.

5 . The device of claim 4 , wherein the locking component interacts with the spooling component to control spooling to adjust tension on the one or more sutures.

6 . The device of claim 1 , wherein the first free-edge clipping implant and the second free-edge clipping implant each include a clip configured to latch onto the free edge of a respective leaflet.

7 . The device of claim 1 , wherein, during delivery, the cinching mechanism is configured to shorten the one or more sutures so that the first free-edge clipping implant and the second free-edge clipping implant are adjacent to the cinching mechanism.

8 . The device of claim 7 , wherein, after delivery to the native valve and prior to attaching the first free-edge clipping implant and the second free-edge clipping implant to respective leaflets, the cinching mechanism is configured to lengthen the one or more sutures.

9 . The device of claim 8 , wherein, after attaching the first free-edge clipping implant and the second free-edge clipping implant to respective leaflets, the cinching mechanism is configured to tension the one or more sutures to approximate the second leaflet and the first leaflet.

10 . The device of claim 9 , wherein the cinching mechanism is configured to be operated by a delivery device that delivered the device to the native valve to tension the one or more sutures.

11 . The device of claim 1 further comprising a third free-edge clipping implant configured to attach to a free edge of the first leaflet or the second leaflet, the one or more sutures joining the third free-edge clipping implant to the cinching mechanism.

12 . The device of claim 1 , wherein the device is delivered via a transcatheter procedure to the native valve.

13 . A device for treating a native valve, the device comprising:
a spacing material configured to be implanted between a first leaflet and a second leaflet; a first paddle coupled to the spacing material, the first paddle comprising a first securing mechanism to secure a portion of the first leaflet to the first paddle; and a second paddle coupled to the spacing material, the second paddle comprising a second securing mechanism to secure a portion of the second leaflet to the second paddle, wherein each paddle is configured to extend and to retract from the spacing material to attach to an edge of a respective leaflet, each paddle having an independently adjustable length to enable each paddle to secure the respective leaflet to the spacing material to reduce prolapse, flail, or valvular regurgitation.

14 . The device of claim 13 , wherein the first securing mechanism and the second securing mechanism each comprise hooks.

15 . The device of claim 13 , wherein a length of each paddle is independently adjusted by manipulating elements at a proximal end of a delivery device.

16 . The device of claim 13 , wherein the first paddle is configured to secure a middle portion of the first leaflet and the second paddle is configured to secure a middle portion of the second leaflet.

17 . The device of claim 13 , wherein, in a deployed configuration, an edge of the first leaflet is configured to be secured by the first securing mechanism of the first paddle and an edge of the second leaflet is configured to be secured by the second securing mechanism of the second paddle.

18 . A device for treating a native valve, the device comprising:
a clip implant configured to be implanted on an atrial side of a leaflet, the clip implant configured to secure an excess portion of the leaflet to reduce leaflet prolapse and/or valvular regurgitation.

19 . A device for treating a native valve, the device comprising:
a first magnetic implant secured to a first leaflet; and a second magnetic implant secured to a second leaflet, magnetic forces between the first magnetic implant and the second magnetic implant sufficient to reduce prolapse, flail, or valvular regurgitation.

20 . A device for treating a native valve, the device comprising:
a tube for drawing in an excess portion of a leaflet; a cauterizing element configured to excise the excess portion of the leaflet; and a clip configured to clip the cauterized portion of the leaflet.

Assignees

• Edwards Lifesciences Corp

Inventors

• Scheinblum Taylor Jacob
• Okabe Hiroshi
• Srinimukesh Harish Manickam
• White Richard D
• Poulsen Nikolai Brent

Classifications

• A61F2/2463 Primary

  Implants forming part of the valve leaflets · CPC title

• A61F2/2457

  Chordae tendineae prostheses · CPC title

• A61F2210/009

  magnetic · CPC title

• A61F2220/0008

  Fixation appliances for connecting prostheses to the body · CPC title

• A61B17/1227

  Spring clips · CPC title