Transcatheter valve prosthesis having an external skirt for sealing and preventing paravalvular leakage

• US 10,213,307 B2
• Filed: 11/05/2014
• Issued: 02/26/2019
• Est. Priority Date: 11/05/2014
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Dwork, Joshua, Mosher, Scott
• Primary Examiner(s): Schillinger, Ann
• Application Number:
  US14/533,541
• Publication Number:
  US 20160120646A1
• Time in Patent Office: 1,574 Days
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2210/00 Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A transcatheter valve prosthesis including a tubular stent includes an interior skirt or skirt portion is coupled to and covers an inner circumferential surface of the stent, and an exterior skirt or skirt portion is coupled to and covers an outer circumferential surface of the stent. A prosthetic valve component is disposed within and secured to the interior skirt or skirt portion. The interior and exterior skirts or skirt portions may overlap to form a double layer of skirt material on the stent, or may be portions of a skirt that do not overlap such that only a single layer of skirt material covers the stent. When the stent is in at least the compressed configuration, at least one endmost crown may be positioned radially inwards with respect to the remaining endmost crowns formed at the inflow end of the stent in order to accommodate the exterior skirt.

Claims

1. A transcatheter valve prosthesis comprising:

a tubular stent including a plurality of openings and having a compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve;

a skirt coupled to the tubular stent, the skirt including only a single layer of skirt material, a first portion of the skirt being attached to and covering an inner circumferential surface of the tubular stent and a second portion of the skirt being attached to and covering an outer circumferential surface of an inflow end of the tubular stent, wherein the skirt is continuous from the first portion to the second portion such that the first and second portions do not overlap and only the single layer of skirt material covers the tubular stent at any longitudinal position thereof and wherein the single layer of skirt material includes a plurality of cuts therein that are positioned to permit the skirt to extend from the inner circumferential surface to the outer circumferential surface of the tubular stent through the plurality of openings; and

a prosthetic valve component disposed within and secured to the first portion of the skirt.

2. The transcatheter valve prosthesis of claim 1,

wherein the tubular stent includes a plurality of crowns and a plurality of struts with each crown being formed between a pair of opposing struts, the tubular stent having endmost crowns formed at the inflow end thereof, and wherein when the tubular stent is in at least the compressed configuration at least one endmost crown is positioned radially inwards with respect to the remaining endmost crowns formed at the inflow end of the tubular stent.

3. The transcatheter valve prosthesis of claim 2, wherein when the tubular stent is in the expanded configuration the at least one endmost crown is positioned radially inwards with respect to the remaining endmost crowns formed at the inflow end of the tubular stent.

4. The transcatheter valve prosthesis of claim 2, wherein the at least one endmost crown is every third endmost crown being positioned radially inwards with respect to the remaining endmost crowns formed at the inflow end of the tubular stent.

5. The transcatheter valve prosthesis of claim 2, wherein the plurality of crowns and the plurality of struts define the plurality of openings of the tubular stent, the tubular stent having endmost openings formed at the inflow end thereof, and wherein the second portion of the skirt extends over the endmost openings of the tubular stent.

6. The transcatheter valve prosthesis of claim 5, wherein the struts that form the endmost opening adjacent to the at least one endmost crown bend radially inwards in order to position the at least one endmost crown radially inwards with respect to the remaining endmost crowns formed at the inflow end of the tubular stent.

7. The transcatheter valve prosthesis of claim 6, wherein the first portion of the skirt longitudinally extends from a proximal end of the second portion of the skirt to the prosthetic valve component.

8. The transcatheter valve prosthesis of claim 1, wherein the tubular stent has endmost openings formed at the inflow end thereof and wherein the second portion of the skirt longitudinally extends over the endmost openings of the tubular stent.

9. The transcatheter valve prosthesis of claim 8, wherein the first portion of the skirt longitudinally extends from a proximal end of the second portion of the skirt to the prosthetic valve component.

10. The transcatheter valve prosthesis of claim 9, wherein each endmost opening includes two pairs of opposing crowns and four struts therebetween and wherein the second portion of the skirt extends over one strut of each endmost opening and is sewn to the other three struts of each endmost opening.

11. The transcatheter valve prosthesis of claim 1, wherein a length of each cut is equal to a length of a strut of the tubular stent.

12. A transcatheter valve prosthesis comprising:

a tubular stent having a compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve, wherein the tubular stent includes a plurality of crowns and a plurality of struts with each crown being formed between a pair of opposing struts, the plurality of crowns and the plurality of struts defining a plurality of openings of the tubular stent;

a skirt coupled to the tubular stent, a first portion of the skirt being attached to and covering an inner circumferential surface of the tubular stent and a second portion of the skirt being attached to and covering an outer circumferential surface of an inflow end of the tubular stent, wherein the skirt is continuous from the first portion to the second portion such that the first and second portions do not overlap and only a single layer of skirt material covers the tubular stent at any longitudinal position thereof, wherein the skirt includes a plurality of cuts therein that are positioned to permit the skirt to extend from the inner circumferential surface to the outer circumferential surface of the tubular stent through the plurality of openings; and

a prosthetic valve component disposed within and secured to the first portion of the skirt.

13. The transcatheter valve prosthesis of claim 12, wherein a length of each cut is equal to a length of a strut of the tubular stent.

14. The transcatheter valve prosthesis of claim 12, wherein each cut forms a first edge on the first portion of the single layer of skirt material and a second edge on the second portion of the single layer of skirt material and a single row of stitches is utilized to couple both the first and second edges to a strut of the tubular stent.

15. A transcatheter valve prosthesis comprising:

a tubular stent having a compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve, wherein the tubular stent includes a plurality of crowns and a plurality of struts with each crown being formed between a pair of opposing struts, the plurality of crowns and the plurality of struts defining a plurality of openings of the tubular stent, and wherein the tubular stent has endmost openings formed at an inflow end thereof;

a skirt coupled to the tubular stent, the skirt including only a single layer of skirt material, a first portion of the skirt being attached to and covering an inner circumferential surface of the tubular stent and a second portion of the skirt being attached to an outer circumferential surface of the inflow end of the tubular stent and covering at least the endmost openings formed at the inflow end of the tubular stent, wherein the skirt is continuous from the first portion to the second portion such that the first and second portions do not overlap and only the single layer of skirt material covers the tubular stent at any longitudinal position thereof and wherein the skirt passes through the plurality of openings of the tubular stent to extend from the inner circumferential surface to the outer circumferential surface of the tubular stent and wherein the single layer of skirt material includes a plurality of cuts therein that are positioned to permit the skirt to extend from the inner circumferential surface to the outer circumferential surface of the tubular stent through the plurality of openings; and

a prosthetic valve component disposed within and secured to the first portion of the skirt.

16. The transcatheter valve prosthesis of claim 15, wherein the single layer of skirt material is a one-piece component and has no seams thereon prior to assembly onto the tubular stent.

17. The transcatheter valve prosthesis of claim 15, wherein the first portion of the skirt longitudinally extends from a proximal end of the second portion of the skirt to the prosthetic valve component.

18. The transcatheter valve prosthesis of claim 15, wherein each endmost opening includes two pairs of opposing crowns and four struts therebetween and wherein the second portion of the skirt extends over one strut of each endmost opening and is sewn to the other three struts of each endmost opening.

19. The transcatheter valve prosthesis of claim 15, wherein a length of each cut is equal to a length of a strut of the tubular stent.

20. The transcatheter valve prosthesis of claim 15, wherein each cut forms a first edge on the first portion of the single layer of skirt material and a second edge on the second portion of the single layer of skirt material and a single row of stitches is utilized to couple both the first and second edges to a strut of the tubular stent.