Heart valve sealing devices and delivery devices therefor

Patent metadata

Field	Value
Publication number	US-10918482-B2
Application number	US-201816173158-A
Country	US
Kind code	B2
Filing date	Oct 29, 2018
Priority date	Apr 18, 2017
Publication date	Feb 16, 2021
Grant date	Feb 16, 2021

Abstract

An exemplary recapturable valve repair system for repairing a native valve of a patient during a non-open heart procedure has a delivery device, a valve repair device, and a tethering line. The delivery device has a catheter and a coupler. The valve repair device is configured to be delivered through the catheter and attach to a native valve of a patient. The valve repair device includes a coaption element, a proximal collar, and first and second paddles. The first and second paddles are connected to the coaption element. The coupler is releasably connected to the proximal collar. The tethering line connects the valve repair device to the delivery device for recapturing the valve repair device.

First claim

The invention claimed is:

1. A recapturable valve repair system for repairing a native valve of a patient during a non-open heart procedure, the recapturable valve repair system comprising:
a delivery device comprising;
a catheter;
a plurality of actuation lines; and
a coupler;
wherein the coupler comprises a plurality of flexible arms;
wherein each one of the plurality of actuation lines is connected to a corresponding one of the plurality of flexible arms;

a valve repair device configured to be delivered with the catheter of the delivery device, and configured to attach to a native valve of a patient, the valve repair device comprising:
a coaption element;
a proximal collar attached to the coaption element; and
first and second paddles connected to the coaption element;

wherein the plurality of flexible arms engage the proximal collar to releasably connect the proximal collar to the coupler;
wherein retraction of the actuation lines moves the plurality of flexible arms in a closing direction; and
a tethering line that connects the valve repair device to the delivery device for recapturing the valve repair device.

2. The valve repair system of claim 1 wherein the delivery device further comprises an actuation shaft that extends through the coupler, the proximal collar, and the coaption element, and wherein the valve repair device further comprises a distal collar, and the actuation shaft is releasably connected to the distal collar.

3. The valve repair system of claim 2 wherein the tethering line extends through the actuation shaft and is connected to the distal collar.

4. The valve repair system of claim 2 wherein movement of the distal collar away from the proximal collar by the actuation shaft opens the first and second paddles.

5. The valve repair system of claim 1 wherein the tethering line extends from the catheter and is connected to the proximal collar.

6. A method of recapturing a valve repair device with a delivery device comprising:
pulling a tethering line that extends through a catheter and a coupler of the delivery device to draw the valve repair device toward the delivery device,
wherein the valve repair device comprises:
a coaption element;
a proximal collar attached to the coaption element; and
first and second paddles connected to the coaption element; and

coupling the coupler to the proximal collar;
engaging the proximal collar with a plurality of flexible arms of the coupler to connect the proximal collar to the coupler by retracting actuation lines that are connected to the plurality of flexible arms to move the plurality of flexible arms in an engaging direction.

7. The method of claim 6 further comprising extending an actuation shaft through the coupler, the proximal collar, and the coaption element.

8. The method of claim 7 further comprising connecting the actuation shaft to the valve repair device.

9. The method of claim 7 further comprising connecting the actuation shaft to a distal collar of the valve repair device.

10. The method of claim 7 wherein the tethering line extends through the actuation shaft and the tethering line is connected to a distal collar.

11. The method of claim 6 wherein the tethering line is connected to the proximal collar.

12. A recapturable valve repair system for repairing a native valve of a patient during a non-open heart procedure, the recapturable valve repair system comprising:
a delivery device comprising:
a catheter;
a coupler having moveable arms; and
an actuation shaft;

a valve repair device configured to be delivered with the catheter of the delivery device, and configured to attach to a native valve of a patient, the valve repair device comprising:
a coaption element;
a proximal collar attached to the coaption element; and
first and second paddles connected to the coaption element;
wherein the moveable arms of the coupler engage apertures of the proximal collar to releasably connect the coupler to the proximal collar;
wherein each moveable arm comprises at least one eyelet;
wherein the actuation shaft extends through the at least one eyelet of each moveable arm to hold the moveable arms in engagement with the proximal collar; and

a tethering line that connects the valve repair device to the delivery device for recapturing the valve repair device.

13. The valve repair system of claim 12 wherein the actuation shaft extends through the coupler, the proximal collar, and the coaption element, and wherein the valve repair device further comprises a distal collar, and the actuation shaft is releasably connected to the distal collar.

14. The valve repair system of claim 13 wherein the tethering line extends through the actuation shaft and is connected to the distal collar.

15. The valve repair system of claim 13 wherein movement of the distal collar away from the proximal collar by the actuation shaft opens the first and second paddles.

16. The valve repair system of claim 12 wherein the tethering line extends from the catheter and is connected to the proximal collar.

17. The valve repair device of claim 12 wherein the movable arms are biased inward to a position where the moveable arms are released from the apertures of the proximal collar.

18. The valve repair device of claim 17 wherein the actuation shaft extends through the coupler and spreads the moveable arms outward to engage the apertures of the proximal collar.

19. The valve repair system of claim 12 wherein the moveable arms are biased to an open position and wherein removal of the actuation shaft from the at least one eyelet of each moveable arm allows the moveable arms to open and release the proximal collar.

20. The valve repair system of claim 19 wherein each of the moveable arms includes a plurality of eyelets.

21. The valve repair system of claim 20 wherein the actuation shaft is reinsertable back into the plurality of eyelets of each moveable arm to reconnect the coupler to the proximal collar.

22. The valve repair device of claim 21 wherein the actuation shaft is inserted into the plurality of eyelets of each moveable arm sequentially and insertion of the actuation shaft into each one of the plurality of eyelets of each moveable arm moves the moveable arms closer together.

23. A method of recapturing a valve repair device with a delivery device comprising:
pulling a tethering line that extends through a catheter and a coupler of the delivery device to draw the valve repair device toward the delivery device;
wherein the valve repair device comprises:
a coaption element;
a proximal collar attached to the coaption element;
wherein the proximal collar includes apertures; and
first and second paddles connected to the coaption element;

biasing arms of the coupler inward to a position where the arms are released from the apertures of the proximal collar;
coupling the coupler to the proximal collar by extending an actuation shaft through the coupler to spread the arms outward to engage the apertures of the proximal collar;
wherein each of the arms comprises at least one eyelet; and
wherein the actuation shaft extends through the at least one eyelet of each arm to hold the arms in engagement with the proximal collar.

24. The method of claim 23 wherein the tethering line is connected to the proximal collar.

25. The method of claim 23 wherein the extending of the actuation shaft through the at least one eyelet of ea

Assignees

• Edwards Lifesciences Corp

Inventors

• Delgado Sergio
• Dixon Eric Robert
• Taylor David M
• Metchik Asher L
• Winston Matthew T
• Sok Sam
• Tyler Ii Gregory Scott
• Freschauf Lauren R
• Siegel Alexander J

Classifications

• A61B17/00

  Surgical instruments, devices or methods (A61B18/00 takes precedence; dental tools A61C3/00; eye surgery A61F9/007; ear surgery A61F11/20) · CPC title

• A61L27/56

  Porous materials, {e.g. foams or sponges} · CPC title

• A61F2/246 Primary

  Devices for obstructing a leak through a native valve in a closed condition · CPC title

• A61B17/0469

  Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery · CPC title

• A61B17/00234 Primary

  for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence) · CPC title