Devices and systems for docking a heart valve

Patent metadata

Field	Value
Publication number	US-11717399-B2
Application number	US-202217583510-A
Country	US
Kind code	B2
Filing date	Jan 25, 2022
Priority date	Feb 5, 2016
Publication date	Aug 8, 2023
Grant date	Aug 8, 2023

Abstract

An expandable stent for implantation in a right ventricular outflow tract includes a frame having a waist portion that expands to a deployed size having a first diameter, first and second sealing portions extending in opposite directions from the waist portion and expanding radially outward of the waist portion. The first and second sealing portions are sized to seal against first and second portions of the inner surface of the right ventricular outflow tract at the deployed position over a range of sizes of expansion larger than the first diameter. A band is secured to the waist portion of the frame, restricting expansion of the waist portion substantially beyond the first diameter, such that the waist portion is configured to be spaced apart from the inner surface of the right ventricular outflow tract at the deployed position.

First claim

The invention claimed is:

1. An expandable stent for implantation in a right ventricular outflow tract, the expandable stent comprising:
a frame including:
a waist portion that expands to a deployed size having a first diameter, the waist portion being defined by at least one row of generally diamond-shaped cells formed by the frame;
a first sealing portion extending from the waist portion and expanding radially outward of the waist portion, wherein the first sealing portion is sized to seal against a first portion of an inner surface of a right ventricular outflow tract at a deployed position over a range of sizes of expansion having a second diameter larger than the first diameter; and
a second sealing portion extending from the waist portion in a direction opposite the first sealing portion and expanding radially outward of the waist portion, wherein the second sealing portion is sized to seal against a second portion of the inner surface of the right ventricular outflow tract at the deployed position over a range of sizes of expansion having a third diameter larger than the first diameter;

a fabric cover secured to the frame at least at the first and second sealing portions; and
a band secured to the waist portion of the frame, the band being separate from and overlapping with the fabric cover and having a width that covers the at least one row of generally diamond-shaped cells without extending beyond the waist portion, the band restricting expansion of the waist portion substantially beyond the first diameter, such that the waist portion is configured to be spaced apart from the inner surface of the right ventricular outflow tract at the deployed position
wherein the fabric cover is secured to an exterior of the frame to define an exterior surface of the expandable stent, and the band is secured to an interior of the frame to define an interior surface of the expandable stent.

2. The expandable stent of claim 1 , wherein the band comprises a fabric.

3. The expandable stent of claim 1 , further comprising a first retaining portion extending axially and radially outward from the first sealing portion, the first retaining portion being configured to engage the right ventricular outflow tract to retain the frame at the deployed position.

4. The expandable stent of claim 3 , wherein the frame further comprises a second retaining portion extending axially and radially outward from the second sealing portion, the second retaining portions being configured to engage the right ventricular outflow tract to retain the frame at the deployed position.

5. The expandable stent of claim 3 , wherein the fabric cover is secured to the frame along the waist portion, the first and second sealing portions and the first retaining portion of the frame.

6. The expandable stent of claim 1 , wherein the frame comprises:
a plurality of struts defining the at least one row of generally diamond-shaped cells in the waist portion, a first end row of generally diamond-shaped cells extending to a first end of the frame, and a second end row of generally diamond-shaped cells extending to a second end of the frame opposite the first end, each cell of the at least one row of generally diamond-shaped cells in the waist portion being positioned in end-to-end alignment with a corresponding cell of the first and second end rows of generally diamond-shaped cells;
wherein the first end row of generally diamond-shaped cells is expandable radially outward to the second diameter, and the second end row of generally diamond-shaped cells is expandable radially outward to the third diameter.

7. The expandable stent of claim 1 , wherein the first diameter is between 24 mm and 30 mm.

8. The expandable stent of claim 1 , wherein the band comprises a polyethylene terephthalate (PET) fabric.

9. The expandable stent of claim 1 , wherein the band is disposed on an inner surface of the frame.

10. The expandable stent of claim 9 , wherein the band defines a valve seat for seating engagement with an expandable prosthetic valve.

11. A valve assembly for implantation in a right ventricular outflow tract, the valve assembly comprising:
a frame including:
a waist portion that expands to a deployed size having a first diameter, the waist portion being defined by at least one row of generally diamond-shaped cells formed by the frame;
a first sealing portion extending from the waist portion and expanding radially outward of the waist portion, wherein the first sealing portion is sized to seal against a first portion of an inner surface of a right ventricular outflow tract at a deployed position over a range of sizes of expansion having a second diameter larger than the first diameter; and
a second sealing portion extending from the waist portion in a direction opposite the first sealing portion and expanding radially outward of the waist portion, wherein the second sealing portion is sized to seal against a second portion of the inner surface of the right ventricular outflow tract at the deployed position over a range of sizes of expansion having a third diameter larger than the first diameter;

a fabric cover secured to the frame at least at the first and second sealing portions;
a band secured to the waist portion of the frame, the band being separate from and overlapping with the fabric cover and having a width that covers the at least one row of generally diamond-shaped cells without extending beyond the waist portion, the band restricting expansion of the waist portion substantially beyond the first diameter, such that the waist portion is configured to be spaced apart from the inner surface of the right ventricular outflow tract at the deployed position; and
a prosthetic valve secured with the frame in alignment with the waist portion;
wherein the fabric cover is secured to an exterior of the frame to define an exterior surface of the expandable stent, and the band is secured to an interior of the frame to define an interior surface of the expandable stent.

12. The valve assembly of claim 11 , wherein the prosthetic valve comprises a plurality of leaflets.

13. The valve assembly of claim 11 , wherein the first diameter is between 24 mm and 30 mm.

14. The valve assembly of claim 11 , wherein the frame further comprises a first retaining portion extending axially and radially outward from the first sealing portion, the first retaining portion being configured to engage the right ventricular outflow tract to retain the frame at the deployed position.

15. The valve assembly of claim 14 , wherein the fabric cover is secured to the frame along the waist portion, the first and second sealing portions and the first retaining portion of the frame.

16. The valve assembly of claim 11 wherein the frame comprises:
a plurality of struts defining the at least one row of generally diamond-shaped cells in the waist portion, a first end row of generally diamond-shaped cells extending to a first end of the frame, and a second end row of generally diamond-shaped cells extending to a second end of the frame opposite the first end, each cell of the at least one row of generally diamond-shaped cells in the waist portion being positioned in end-to-end alignment with a corresponding cell of the first and second end rows of generally diamond-shaped cells;
wherein the first end row of generally diamond-shaped cells is expandable radially outward to the second diameter, and the second end row of generally diamond-shaped cells is expandable radially outward to the third diameter.

17. The valve assembly of claim 11 , wherein the band is dispose

Assignees

• Edwards Lifesciences Corp

Inventors

• Armer Dustin P
• Franklin Michael D
• Delgado Sergio
• Joshi Abhijeet
• Sirimanne Dinesh L
• Joseph Russell T
• Abbott Eason Michael
• Nguyen Tram Ngoc
• Nguyen Son V
• Ngo Hien Tran
• Tran Vivian
• Bowman Charles L
• Rowe Stanton J

Classifications

• A61F2/2466

  Delivery devices therefor · CPC title

• A61F2/2427 Primary

  Devices for manipulating or deploying heart valves during implantation · CPC title

• A61F2/2409 Primary

  Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442) · CPC title

• A61F2/24

  Heart valves {; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body} · CPC title

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title