Prosthetic heart valve system and delivery system therefor

• US 10,512,539 B2
• Filed: 12/04/2015
• Issued: 12/24/2019
• Est. Priority Date: 12/05/2014
• Status: Active Grant

• Current Assignee: NVT AG (Blue Sail Medical Co., Ltd.)
• Original Assignee: NVT AG (Blue Sail Medical Co., Ltd.)
• Inventors: Centola, Marcos, Kawa, Emilia
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US14/959,480
• Publication Number:
  US 20160158007A1
• Time in Patent Office: 1,481 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular

Abstract

A prosthetic heart valve system and a delivery system therefor, the prosthetic heart valve system comprising a heart valve element with expandable generally tubular stent support forming a wire frame, wherein the tubular stent support comprises a plurality of adjacent rows of interconnected, substantially diamond-shaped cell structures extending, along and in parallel to the longitudinal direction, between the proximal end and distal end, and wherein the stent support, in a medial portion, comprises a circumferential row of a plurality of wire anchor structures which wire anchor structures are spaced from one another and attached to the wire frame and which, in respect to the longitudinal axis of the stent support, at least partially protrude outward at an angle α. The prosthetic heart valve system may also comprise a stent(graft)-element.

Claims

1. A prosthetic heart valve system for replacement of a native valve of a patient, wherein the prosthetic heart valve system comprises a prosthetic heart valve element comprising:

an expandable generally tubular stent support forming a wire frame and having a proximal end, a distal end, a longitudinal axis extending from the proximal end to the distal end, and a circumference, wherein the tubular stent support comprises a plurality of adjacent rows of interconnected, substantially diamond-shaped cell structures extending, along and in parallel to the longitudinal direction, between the proximal end and distal end;

wherein each diamond-shaped cell structure defines four corners, a top corner, a bottom corner and two side corners, and wherein the stent support, in a medial portion, which is located between the distal end and the proximal end and which is designed such that it is positionable at least partially in an annulus of the native valve, has a diameter that is smaller than the diameter at the distal and the proximal end, and that at the medial portion the stent support comprises a circumferential row of a plurality of wire anchor structures which wire anchor structures are spaced from one another and—

via the two side corners and not via the top corner or the bottom corner of at least some of the diamond-shaped cell structures—

attached to at least some of the diamond-shaped cell structures of the wire frame, an attachment point of each of the wire anchor structures being at an interconnecting point where two adjacent diamond-shaped wire cell structures in a row meet, and which, in respect to the longitudinal axis of the stent support, the wire anchor structures at least partially protrude outward at an angle α

, wherein each of the wire anchor structures of the plurality of wire anchor structures have an end that protrudes outwardly and toward the proximal end of the stent support, wherein the ends that protrude outwardly toward the proximal end of the stent support are configured to anchor the tubular stent support to the annulus of the native valve

wherein, in the distal end a last row of the diamond-shaped cell structures has free top corners not interconnected with a respective other diamond-shaped cell structure, and

wherein some of the top corners comprise connecting wire extension structures, and

wherein the prosthetic heart valve element further comprises a valve structure having a plurality of valve leaflets, a valve skirt, and a plurality of valve commissure points, and wherein the valve structure is attached within an interior surface of the stent support, such, that in a proximal portion of the inner surface of the tubular stent support is lined with the valve structure forming a sealing zone, and that the valve structure, via its commissure points, is fixed to the stent support.

2. The prosthetic heart valve system of claim 1, wherein the angle α

the wire anchor structures are protruding outwardly is between 90° and

5°

.

3. The prosthetic heart valve system of claim 2, wherein the angle α

the wire anchor structures are protruding outwardly is between 50° and

25°

.

4. The prosthetic heart valve system of claim 3, wherein the angle α

the wire anchor structures are protruding outwardly is about 45°

.

5. The prosthetic heart valve system of claim 1, wherein the prosthetic heart valve element comprises an outer sheet at least covering the row of a plurality of wire anchor structures of the stent support.

6. The prosthetic heart valve system of claim 5, wherein the outer sheet comprises a polymer material or biological tissue.

7. The prosthetic heart valve system of claim 1, wherein the prosthetic heart valve element comprises an outer sheet which covers and extends from the medial portion comprising the row of a plurality of wire anchor structures to the distal end of the stent support.

8. The prosthetic heart valve system of claim 1, wherein the wire anchor structures each represent a single longitudinal wire portion having a first and a second end, the first end being attached to the tubular stent support, and the second end being free and protruding outwardly.

9. The prosthetic heart valve system of claim 8, wherein the free second end of the wire portion comprises a curve bended substantially parallel relative to the longitudinal axis of the of the tubular stent support, or bended towards the longitudinal axis of the tubular stent support.

10. The prosthetic heart valve system of claim 1, wherein the wire anchor structures each represent a substantially V-shaped wire cell structure.

11. The prosthetic heart valve system of claim 10, wherein each of the substantially V-shaped wire cell structures has two wire segments each comprising a first and a second end, wherein the first ends of the segments meet in a vertex and the second ends are attached to the wire frame of the stent support in a certain distance from one another such, that a substantially V-shaped cell structure is formed, with the vertex protruding outward.

12. The prosthetic heart valve system of claim 11, wherein the second ends of the wire segments are attached to interconnecting points where two adjacent diamond-shaped wire cells structures of the adjacent rows of interconnected, substantially diamond-shaped cell structures meet.

13. The prosthetic heart valve system of claim 1, wherein the prosthetic heart valve element, at its distal end, comprises three substantially V-shaped openings in its circumference which V- or U-shaped openings open towards the distal end of the stent support.

14. The prosthetic heart valve system of claim 1, wherein the proximal end and the distal end of the stent support each comprises a crown of a plurality of free peaks pointing in the proximal and distal direction, respectively, and wherein the distal end of the stent support, in its crown, has only three free peaks all of which peaks have a connecting wire extension structure.

15. The prosthetic heart valve system of claim 1, further comprising a stent- or stentgraft-element which is connectable with the prosthetic heart valve element.

16. The prosthetic heart valve system of claim 15, wherein the stent- or stentgraft-element is connectable with the prosthetic heart valve element via ligament-like connecting means fixedly attached to the stent- or stentgraft-element.

17. The prosthetic heart valve system of claim 16, wherein the ligament-like connecting means comprise flexible bar-formed structures.

18. A prosthetic heart valve system for replacement of a native valve of a patient, wherein the prosthetic heart valve system comprises a prosthetic heart valve element comprising:

an expandable generally tubular stent support forming a wire frame and having a proximal end, a distal end, a longitudinal axis extending from the proximal end to the distal end, and a circumference, wherein the tubular stent support comprises a plurality of adjacent rows of interconnected, substantially diamond-shaped cell structures extending, along and in parallel to the longitudinal direction, between the proximal end and distal end;

wherein the stent support, in a medial portion, which is located between the distal end and the proximal end and which is designed such that it is positionable at least partially in an annulus of the native valve, has a diameter that is smaller than the diameter at the distal and the proximal end, and that at the medial portion the stent support comprises a circumferential row of a plurality of wire anchor structures which wire anchor structures are spaced from one another and which, in respect to the longitudinal axis of the stent support, at least partially protrude outward at an angle α

, wherein the wire anchor structures each represent a substantially V-shaped wire cell structure, wherein each of the substantially V-shaped wire cell structures has two wire segments each comprising a first and a second end, wherein the first ends of the segments meet in a vertex and the second ends are attached to the wire frame of the stent support in a certain distance from one another such, that a substantially V-shaped cell structure is formed, with the vertex protruding outward, wherein the second ends of the wire segments are attached to interconnecting points where two adjacent diamond-shaped wire cells structures of the adjacent rows of interconnected, substantially diamond-shaped cell structures meet, and

wherein the prosthetic heart valve element further comprises a valve structure having a plurality of valve leaflets, a valve skirt, and a plurality of valve commissure points, and wherein the valve structure is attached within an interior surface of the stent support, such, that in a proximal portion of the inner surface of the tubular stent support is lined with the valve structure forming a sealing zone, and that the valve structure, via its commissure points, is fixed to the stent support.