Multi-component designs for heart valve retrieval device, sealing structures and stent assembly

• US 9,895,221 B2
• Filed: 01/28/2015
• Issued: 02/20/2018
• Est. Priority Date: 07/28/2012
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Inventors: Vidlund, Robert
• Primary Examiner(s): Schillinger, Ann
• Application Number:
  US14/607,888
• Publication Number:
  US 20150142103A1
• Time in Patent Office: 1,119 Days
• Field of Search: None
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

This invention relates to the design and function of a device which allows for retrieval of a previously implanted valve prosthesis from a beating heart without extracorporeal circulation using a transcatheter retrieval system, including a guide component to facilitate the compression of the valve and retraction into a retrieval catheter, as well as an improved prosthetic transcatheter heart valve having one or more of: a series of radially extending tines having a loop terminus to improve sealing a deployed prosthetic mitral valve against hemodynamic leaking, a pre-compressible stent-in-stent design, or an articulating cuff attached to a covered stent-valve and a commissural sealing skirt structure attached to the underside of the articulating cuff.

Claims

1. A prosthetic mitral valve comprising:

an outer stent having an atrium end;

a circumferentially continuous tissue collar for atrial sealing, supported by a first end of said outer stent;

an inner stent having a diameter smaller than a diameter of said outer stent and being disposed in said outer stent such that a gap is defined between said outer stent and said inner stent, said tissue collar being coupled to a first end of said inner stent such that said tissue collar extends across the gap from said outer stent to said inner stent to limit flow through the gap;

a leaflet apparatus disposed in said inner stent;

a plurality of wire tethers each having a first end coupled to a ventricle end of said outer stent and extending therefrom, each of said plurality of wire tethers having a second end;

a junction nut coupled to said second ends of said plurality of wire tethers; and

an anchoring tether coupled to and extending from said junction nut.

2. The valve of claim 1, wherein said leaflet apparatus is disposed in a ventricle section of said inner stent proximate to said ventricle end of said outer stent.

3. The valve of claim 1, wherein said atrium end of said outer stent includes a plurality of articulating arms extending radially therefrom, said tissue collar being supported on said plurality of articulating arms.

4. The valve of claim 1, wherein said tissue collar is integrally formed with said outer stent.

5. The valve of claim 1, wherein said tissue collar is formed separately from and coupled to said outer stent.

6. The valve of claim 1, further comprising:

a tissue covering disposed about an interior portion of said outer stent.

7. The valve of claim 1, wherein said outer stent extends longitudinally from said atrium end of said outer stent to a ventricle end of said outer stent opposite to said atrium end of said outer stent, said tissue collar extending radially from said atrium end of said outer stent.

8. The valve of claim 1, wherein said tissue collar is further coupled to a first end of said inner stent, creating a subvalvular chamber between said inner stent, said outer stent, and said tissue collar.

9. The valve of claim 1, wherein said outer stent is configured to extend from an atrium of a heart to a ventricle of said heart and said tissue collar is configured to extend radially in said atrium of said heart, when said valve is seated in a native atrioventricular annulus of said heart.

10. The valve of claim 1, wherein said tissue collar is configured to conform to an anatomical shape of an annulus of a heart and maintain said conformity during a cardiac cycle of said heart.

11. The valve of claim 1, wherein multiple interior portions of said outer stent are spaced apart radially from said inner stent.

12. The valve of claim 1, wherein the first end of the outer stent is the same end as the atrium end of the outer stent.

13. The valve of claim 1, wherein the tissue collar is supported by a first end of said outer stent.

14. The valve of claim 13, wherein the first end of the outer stent is the same end as the atrium end of the outer stent.

15. A prosthetic mitral valve comprising:

an outer tubular stent having a distal end and a proximal end;

a circumferentially continuous tissue collar for atrial sealing, supported by an end of said outer tubular stent;

an inner tubular stent having a diameter smaller than a diameter of said outer tubular stent and being disposed in said outer tubular stent such that a gap is defined between said outer tubular stent and said inner stent, said tissue collar being coupled to a first end of said inner stent such that said tissue collar extends across the gap from said outer tubular stent to said inner stent to limit flow through the gap;

a plurality of wire tethers each having a first end coupled to the proximal end of said outer tubular stent and extending therefrom, each of said plurality of wire tethers having a second end;

a junction nut coupled to said second ends of said plurality of wire tethers;

an anchoring tether coupled to and extending from said junction nut; and

a leaflet apparatus disposed in said inner tubular stent.

16. The valve of claim 15, wherein said tissue collar is further coupled to the distal end of said inner tubular stent, creating a subvalvular chamber between said inner stent, said outer stent, and said tissue collar.

17. The valve of claim 15, wherein said leaflet apparatus is disposed in a lower section of said inner tubular stent proximate to said distal end of said outer tubular stent.

18. The valve of claim 15, wherein said distal end of said outer tubular stent includes a plurality of articulating arms extending radially therefrom, said tissue collar being supported on said plurality of articulating arms.

19. The valve of claim 15, wherein the end of the outer tubular stent that supports the tissue collar is the distal end of the outer tubular stent.