Arrangement, a loop-shaped support, a prosthetic heart valve and a method of repairing or replacing a native heart valve

• US 10,321,989 B2
• Filed: 09/26/2016
• Issued: 06/18/2019
• Est. Priority Date: 01/24/2012
• Status: Active Grant

• Current Assignee: Medtentia International Ltd. Oy
• Original Assignee: Medtentia International Ltd. Oy
• Inventors: Keranen, Olli
• Primary Examiner(s): Bui, Vy
• Application Number:
  US15/275,903
• Publication Number:
  US 20170007399A1
• Time in Patent Office: 995 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/006 modular

Abstract

The present disclosure relates to an arrangement, a loop-shaped support, a prosthetic heart valve and a method of repairing or replacing a native heart valve. With the method or the arrangement, leakage or regurgitation between a prosthetic heart valve and the surrounding valve tissue is prevented. In one embodiment, an arrangement for replacement or repair of a native heart valve is provided, which comprises a loop-shaped support 41 and a prosthetic heart valve 70 and wherein an outer segment 32 of the loop-shaped support 41 is positionable towards surrounding valve tissue of a native heart valve and wherein an outer surface 74 of the prosthetic heart valve 70 is positionable towards an inner segment 34 of the loop-shaped support 41 so as to prevent paravalvular leakage or regurgitation between the prosthetic heart valve 70 and the surrounding valve tissue of the native heart valve.

Claims

1. A method of repairing or replacing a native heart valve, comprising:

positioning a loop-shaped support comprising an inner segment and an outer segment at an annulus of a native heart valve so that said outer segment of said loop-shaped support is positioned against said annulus or surrounding valve tissue, wherein, after delivery to a target site, the loop-shaped support has a helical shape comprising a first loop and a second loop each positioned in substantially different diametric planes;

advancing a prosthetic heart valve through said first loop and said second loop, said first loop and said second loop having a circumference which is larger than a circumference of said prosthetic heart valve; and

radially downsizing said first loop and said second loop to position an outer surface of said prosthetic heart valve towards said inner segment, so as to prevent paravalvular leakage or regurgitation between said prosthetic heart valve and said annulus of said native heart valve.

2. The method of claim 1, wherein said inner segment is adapted for receiving a radially expandable prosthetic heart valve.

3. The method of claim 2, further comprising:

delivering said loop-shaped support transvascularly via a catheter; and

delivering said prosthetic heart valve transvascularly via a catheter.

4. The method of claim 1, wherein said loop-shaped support is radially rigid for preventing an expansion of said prosthetic heart valve beyond said inner segment.

5. The method of claim 4, further comprising:

delivering said loop-shaped support transvascularly via a catheter; and

delivering said prosthetic heart valve transvascularly via a catheter.

6. The method of claim 1, wherein said prosthetic heart valve is rigid and said method further comprising:

tightly positioning said outer surface of said prosthetic heart valve towards said inner segment of said loop-shaped support so as to seal the area between said prosthetic heart valve and said loop-shaped support.

7. The method of claim 6, further comprising:

delivering said loop-shaped support transvascularly via a catheter; and

delivering said prosthetic heart valve transvascularly via a catheter.

8. The method of claim 1 further comprising:

radially downsizing said first loop and said second loop of said loop-shaped support to fit tightly around said prosthetic heart valve so as to seal the area between said prosthetic heart valve and said loop-shaped support.

9. The method of claim 8, further comprising:

delivering said loop-shaped support transvascularly via a catheter; and

delivering said prosthetic heart valve transvascularly via a catheter.

10. The method of claim 1, further comprising:

delivering said loop-shaped support transseptally via a catheter; and

delivering said prosthetic heart valve transseptally via a catheter.

11. The method of claim 1, further comprising:

delivering said loop-shaped support transapically via a catheter; and

delivering said prosthetic heart valve transapically via a catheter.

12. The method of claim 1, further comprising:

delivering said loop-shaped support transvascularly via a catheter; and

delivering said prosthetic heart valve transvascularly via a catheter.

13. The method of claim 1, further comprising:

anchoring said prosthetic heart valve on a ventricular side of a patient'"'"'s heart with three or more anchor elements integrated with said prosthetic heart valve, said anchor elements being positioned on said ventricular side of said prosthetic heart valve, distributed equally around said prosthetic heart valve and extending outwards from said prosthetic heart valve.

14. The method of claim 13, further comprising:

anchoring said prosthetic heart valve on the atrial side of a patient'"'"'s heart with three or more anchor elements integrated with said prosthetic heart valve, said anchor elements being positioned on the atrial side of said prosthetic heart valve, distributed equally around said prosthetic heart valve and extending outwards from the prosthetic heart valve.

15. A method of repairing or replacing a native heart valve, comprising:

delivering a loop-shaped support to a target site, wherein, after delivery to the target site, the loop-shaped support has a helical shape comprising a first loop and a second loop each positioned in substantially different diametric planes;

advancing a radially expandable prosthetic heart valve through the loop-shaped support, wherein said loop-shaped support has a circumference which is larger than a circumference of said prosthetic heart valve; and

radially downsizing said first loop and said second loop of said loop-shaped support to fit tightly around said prosthetic heart valve so as to seal the area between said prosthetic heart valve and said loop-shaped support.

16. The method of claim 15, further comprising:

positioning an outer segment of said loop-shaped support towards an annulus of the native heart valve or surrounding valve tissue.

17. The method of claim 15, wherein the loop-shaped support comprises a fabric flange unit, said flange unit being connected to said loop-shaped support, the method further comprising;

attaching the flange unit against the annulus for positioning the loop-shaped support at the annulus.