Flexible canopy valve repair systems and methods of use

Patent metadata

Field	Value
Publication number	US-11701228-B2
Application number	US-202117339353-A
Country	US
Kind code	B2
Filing date	Jun 4, 2021
Priority date	Mar 20, 2018
Publication date	Jul 18, 2023
Grant date	Jul 18, 2023

Abstract

A system for treating valvular regurgitation in a heart valve includes a flexible canopy and an elongated tether including an elastic portion and an inelastic portion. When the system is in a deployed configuration, a proximal end of the flexible canopy is coupled to an annulus of the heart valve and a distal end of the elongated tether is coupled to a ventricle. The flexible canopy is configured to overlay a first native leaflet of the heart valve, and tension on the elongated tether is applied and/or adjusted to prevent the first leaflet from prolapsing, to maximize coaptation of the flexible canopy with a second native leaflet of the heart valve, and to minimize regurgitation of the heart valve.

First claim

What is claimed is:

1. A system for treating a native heart valve, the system including a delivery configuration and a deployed configuration, the system comprising:
a flexible canopy;
an elongated tether configured to be placed under tension in situ, the elongated tether including an elastic portion and an inelastic portion coupled to the elastic portion, wherein the elastic portion is at least as long as the inelastic portion with a ratio of the elastic portion to the inelastic portion being between 50/50 and 70/30 and a proximal end of the elongated tether is attached to a distal end of the flexible canopy; and
a distal anchor configured to be embedded into tissue of a ventricle, wherein a distal end of the elongated tether is coupled to the distal anchor,
wherein when the system is in the deployed configuration, a proximal end of the flexible canopy is anchored to an annulus of the heart valve and the distal end of the elongated tether is anchored to tissue of a ventricle via the distal anchor such that the elongated tether is placed under tension.

2. The system of claim 1 , wherein the flexible canopy includes a first surface and a second surface opposite the first surface, wherein when the system is in the deployed configuration, the first surface of the flexible canopy overlays to an underlying first surface of a first leaflet of the heart valve, and the system is configured to prevent the first leaflet of the heart valve from prolapsing, and to permit a portion of the second surface of the flexible canopy to coapt with at least an opposing mating portion of a second leaflet of the heart valve.

3. The system of claim 2 , further comprising: a frame coupled to a portion of the flexible canopy.

4. The system of claim 2 , wherein the flexible canopy is unsupported and does not include a frame coupled thereto.

5. The system of claim 2 , wherein the first surface of the flexible canopy includes at least one micro-barb and the at least one micro-barb is configured to couple the first surface of the flexible canopy to the underlying first surface of the first leaflet of the heart valve.

6. The system of claim 1 , wherein the inelastic portion of the elongated tether is positioned distal of the elastic portion of the elongated tether.

7. The system of claim 1 , wherein the elastic portion of the elongated tether is positioned distal of the inelastic portion of the elongated tether.

8. The system of claim 1 , wherein the elastic portion of the elongated tether is longer than the inelastic portion of the elongated tether.

9. The system of claim 1 , wherein the elastic portion of the elongated tether is a spring.

10. The system of claim 1 , wherein the distal anchor is helical.

11. A system for treating a native heart valve, the system including a delivery configuration and a deployed configuration, the system comprising:
a flexible canopy and a frame attached to the flexible canopy to provide structural support thereto;
an elongated tether configured to be placed under tension in situ, the elongated tether including an elastic portion and an inelastic portion coupled to the elastic portion, wherein the elastic portion is at least as long as the inelastic portion with a ratio of the elastic portion to the inelastic portion being between 50/50 and 70/30 and a proximal end of the elongated tether is attached to a distal end of the flexible canopy; and
a distal anchor configured to be embedded into tissue of a ventricle, wherein a distal end of the elongated tether is coupled to the distal anchor,
wherein when the system is in the deployed configuration, a proximal end of the flexible canopy is anchored to an annulus of the heart valve and the distal end of the elongated tether is anchored to tissue of a ventricle via the distal anchor such that the elongated tether is placed under tension.

12. The system of claim 11 , wherein the flexible canopy has a first surface and a second surface opposite the first surface, wherein when the system is in the deployed configuration, the first surface of the flexible canopy overlays an underlying first surface of a first leaflet of the heart valve, and the system is configured to prevent the first leaflet of the heart valve from prolapsing, and to permit a portion of the second surface of the flexible canopy to coapt with at least an opposing mating portion of a second leaflet of the heart valve.

13. The system of claim 12 , wherein the first surface of the flexible canopy includes at least one micro-barb and the at least one micro-barb is configured to couple the first surface of the flexible canopy to the underlying first surface of the first leaflet of the heart valve.

14. The system of claim 11 , wherein the inelastic portion of the elongated tether is positioned distal of the elastic portion of the elongated tether.

15. The system of claim 11 , wherein the elastic portion of the elongated tether is positioned distal of the inelastic portion of the elongated tether.

16. The system of claim 11 , wherein the elastic portion of the elongated tether is longer than the inelastic portion of the elongated tether.

17. The system of claim 11 , wherein the elastic portion of the elongated tether is a spring.

18. The system of claim 11 , wherein the distal anchor is helical.

19. The system of claim 11 , wherein the frame has a shape that follows a perimeter of the flexible canopy.

20. The system of claim 11 , wherein the frame is formed from a nickel titanium alloy.

Assignees

• Medtronic Vascular Inc

Inventors

• Genovese Matthew
• Sandstrom Jeffrey
• Pribanic Russell
• Mcpeak Thomas
• Lee Vania
• O'Brien Dermot
• Allan James Calvin

Classifications

• A61F2/2454 Primary

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

• A61F2/2457

  Chordae tendineae prostheses · CPC title

• A61F2/2463

  Implants forming part of the valve leaflets · CPC title

• A61B17/0401

  Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors (A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811) · CPC title

• A61B2017/00243

  cardiac · CPC title