Heart valve sealing devices and delivery devices therefor

Patent metadata

Field	Value
Publication number	US-12011353-B2
Application number	US-201916522605-A
Country	US
Kind code	B2
Filing date	Jul 25, 2019
Priority date	May 14, 2015
Publication date	Jun 18, 2024
Grant date	Jun 18, 2024

Abstract

In one representative embodiment, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion. The prosthetic device can be movable between multiple configurations. The spacer body can be configured to extend radially outwardly as the spacer body extends away from the distal end toward the proximal end. A delivery apparatus can have a first shaft and a second shaft, wherein movement of the first shaft relative to the second shaft moves the anchor portion relative to the spacer body.

First claim

We claim:

1. An implantable prosthetic device for connection to native heart valve leaflets, comprising:
a spacer body that is configured such that the spacer body can (i) be disposed between native valve leaflets of a heart, (ii) block blood flow through the spacer body from an atrial side of the spacer body to a ventricular side of the spacer body, (iii) block blood flow through the spacer body from the ventricular side of the spacer body to the atrial side of the spacer body, and (iv) divide an orifice between a ventricle and an atrium such that the native heart valve leaflets can (a) open at two sides of the spacer body into two orifices during diastole to allow blood flow from the atrium to the ventricle through the two orifices, and (b) coapt to inhibit blood flow from the ventricle to the atrium during systole;
wherein the spacer body has a proximal end and a distal end;
wherein the spacer body extends radially outwardly as the spacer body extends away from the distal end toward the proximal end;
at least one anchor portion coupled to the distal end of the spacer body, wherein the at least one anchor portion is placed against a ventricular surface of a corresponding one of the native heart valve leaflets; and
a shaft that extends through the spacer body and that is coupled to the at least one anchor portion, wherein the shaft is configured to change the size of the spacer body.

2. The implantable prosthetic device of claim 1 further comprising a cap coupled to the at least one anchor portion.

3. The implantable prosthetic device of claim 1 wherein each of the at least one anchor portion includes an upper leg portion coupled to the distal end of the spacer body and a lower leg portion connected to the upper leg portion by a joint.

4. The implantable prosthetic device of claim 2 wherein each of the at least one anchor portion includes an upper leg portion coupled to the distal end of the spacer body and a lower leg portion connected to the upper leg portion by a joint, wherein a distal end of the lower leg portion is fixedly secured to the cap.

5. The implantable prosthetic device of claim 1 wherein the spacer body and the at least one anchor portion are made from a single piece of braided self-expandable metallic thread.

6. The implantable prosthetic device of claim 3 wherein the spacer body and the at least one anchor portion are made from a single piece of braided self-expandable metallic thread.

7. The implantable prosthetic device of claim 1 wherein the spacer body is covered with a blood impervious material.

8. The implantable prosthetic device of claim 3 wherein the spacer body and the at least one anchor portion are covered with a blood impervious material.

9. The implantable prosthetic device of claim 1 wherein the spacer body is made from braided self-expandable metallic thread.

10. The implantable prosthetic device of claim 1 wherein the spacer body is configured such that compressing ends of the spacer body axially foreshortens the spacer body axially and expands the spacer body radially.

11. An assembly, comprising:
an implantable prosthetic device having a spacer body, a plurality of anchors, and an end cap; and
a delivery apparatus having a first shaft and a second shaft;
wherein the spacer body extends radially outwardly as the spacer body extends from the distal end toward the proximal end and is configured to divide an orifice between a ventricle and an atrium into two orifices;
wherein the plurality of anchors is coupled to the spacer body;
wherein the plurality of anchors is coupled to the end cap;
wherein the plurality of anchors is placed against ventricular surfaces of native heart valve leaflets;
wherein the first shaft is coupled to the end cap;
wherein the second shaft is coupled to a proximal end of the spacer body;
wherein movement of the first shaft relative to the second shaft moves the anchors relative to the spacer body.

12. The assembly of claim 11 wherein each of the plurality of anchors includes an upper leg portion coupled to the distal end of the spacer body and a lower leg portion connected to the upper leg portion by a joint.

13. The assembly of claim 11 wherein each of the plurality of anchors includes an upper leg portion coupled to the distal end of the spacer body and a lower leg portion connected to the upper leg portion by a joint, wherein a distal end of the lower leg portion is fixedly secured to the end cap.

14. The assembly of claim 11 wherein the spacer body and at least one of the plurality of anchors are made from a single piece of braided self-expandable metallic thread.

15. The assembly of claim 12 wherein the spacer body and at least one of the plurality of anchors are made from a single piece of braided self-expandable metallic thread.

16. The assembly of claim 11 wherein the spacer body is covered with a blood impervious material.

17. The assembly of claim 11 wherein the spacer body and at least one of the plurality of anchors are covered with a blood impervious material.

18. An assembly, comprising:
an implantable prosthetic device having a spacer body, a plurality of anchors, and an end cap; and
a delivery apparatus having a first shaft and a second shaft;
wherein the spacer body extends radially outwardly as the spacer body extends from the distal end toward the proximal end and is configured to divide an orifice between a ventricle and an atrium into two orifices;
wherein the plurality of anchors is coupled to the spacer body;
wherein the plurality of anchors is coupled to the end cap;
wherein the plurality of anchors is placed against ventricular surfaces of native heart valve leaflets;
wherein the first shaft is coupled to the end cap;
wherein the second shaft is coupled to a proximal end of the spacer body;
wherein movement of the first shaft relative to the second shaft moves the anchors relative to the spacer body;
wherein each of the plurality of anchors includes an upper leg portion coupled to the distal end of the spacer body and a lower leg portion connected to the upper leg portion by a joint; and
wherein the spacer body is covered with a material that inhibits blood flow.

Assignees

• Edwards Lifesciences Corp

Inventors

• Chau Mark
• Taylor David M
• Siegel Alexander J
• Olson Christopher J
• Delgado Sergio
• Cooper Alexander H
• Freschauf Lauren R
• Metchik Asher L
• Winston Matthew T
• Hernandez Cristobal R
• Karapetian Emil
• Khuu Bao
• Dixon Eric Robert

Classifications

• A61F2230/0008

  elliptical or oval · CPC title

• A61F2/2463

  Implants forming part of the valve leaflets · CPC title

• A61F2310/00023

  Titanium or titanium-based alloys, e.g. Ti-Ni alloys · CPC title

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title

• A61F2/2454 Primary

  Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses · CPC title