Transcatheter stent and valve assembly

• US 10,610,357 B2
• Filed: 10/10/2017
• Issued: 04/07/2020
• Est. Priority Date: 10/10/2016
• Status: Active Grant

• Current Assignee: PECA Labs, Inc.
• Original Assignee: PECA Labs, Inc.
• Inventors: Bernstein, C. Douglas, Kalra, Arush, Faulk, Denver
• Primary Examiner(s): Prone, Christopher D.
• Application Number:
  US15/729,580
• Publication Number:
  US 20180098845A1
• Time in Patent Office: 910 Days
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/2415 Manufacturing methods
• 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 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0023 differing in porosity
• CPC Class Codes: A61F 2250/0024 made from both porous and non-porous parts, e.g. adjacent parts

Abstract

Valves constructed from low porosity leaflets are disclosed. The valves disclosed herein may be integrated into a variety of structures, such as valved conduits and transcatheter stents, and may be constructed of one or more layers. Embodiments herein are also directed to methods of using the same and methods of making the same.

Claims

1. A transcatheter stent comprising:

a stent having a first annular row of a plurality of chevron shaped structures, and a second annular row of a plurality of chevron shaped structures;

wherein the plurality of chevron shaped structures of the first and second annular rows oppose each other when the stent is in a collapsed configuration and when the stent is in an expanded configuration, and wherein the plurality of chevron shaped structures of the first and second annular rows each have a first V-shaped structure having a proximal median vertex, a second V-shaped structure having a distal median vertex, and the first and second V-shaped structures are connected by a pair of lateral edges to form a closed polygon,

the stent having an inner surface and an outer surface; and

a valve attached to the inner surface of the stent at a plurality of attachment points, wherein at least one attachment point of the plurality of attachment points is at the proximal median vertex or the distal median vertex of the first annular row, and wherein at least one attachment point of the plurality of attachment points is at the proximal median vertex or the distal median vertex of the second annular row.

2. The transcatheter stent of claim 1, wherein within each chevron shaped structure, a distance between the proximal median vertex and the distal median vertex is substantially the same in the collapsed configuration and the expanded configuration.

3. The transcatheter stent of claim 1, wherein the plurality of attachment points rotate between collapsed configuration and the expanded configuration.

4. The transcatheter stent of claim 1, wherein the plurality of attachment points undergo equal translation between the collapsed configuration and the expanded configuration.

5. The transcatheter stent of claim 1, wherein the valve comprises one or more leaflets composed of a non-stretching material.

6. The transcatheter stent of claim 5, wherein within each chevron shaped structure, a distance between the proximal median vertex and the distal median vertex is substantially the same in the collapsed configuration and the expanded configuration.

7. The transcatheter stent of claim 5, wherein the plurality of attachment points undergo equal translation between the collapsed configuration and the expanded configuration.

8. The transcatheter stent of claim 5, wherein a member associated with one attachment point of the plurality of attachment points rotates between the collapsed configuration and the expanded configuration.

9. The transcatheter stent of claim 5, wherein a member associated with one attachment point of the plurality of attachment points rotates during the transition between collapsed configuration and expanded configuration.

10. The transcatheter stent of claim 1, wherein the first annular row has 4 to 24 chevron shaped structures, and the second annular row has 4 to 24 chevron shaped structures.

11. A transcatheter stent comprising:

a stent having

a proximal portion and a distal portion, each comprising a plurality of spindle-shaped structures, and

an intermediate portion comprising,

a first annular row of a plurality of chevron shaped structures, and

a second annular row of a plurality of chevron shaped structures, wherein the first annular row and the second annular row oppose each other when the stent is in a collapsed configuration and when the stent is in an expanded configuration, and wherein the plurality of chevron shaped structures of the first and second annular rows each have a first V-shaped structure having a proximal median vertex and a second V-shaped structure having a distal median vertex, and the first and second V-shaped structures are connected by a pair of lateral edges to form a closed polygon.

12. The transcatheter stent of claim 11, further comprising a valve disposed within the intermediate portion of the stent.

13. The transcatheter stent of claim 12, wherein the valve is attached to the intermediate portion of the stent at a plurality of attachment points, wherein at least one attachment point of the plurality of attachment points is at the proximal median vertex or the distal median vertex of the first annular row, and wherein at least one attachment point of the plurality of attachment points is at the proximal median vertex or the distal median vertex of the second annular row.

14. The transcatheter stent of claim 13, wherein within each chevron shaped structure, a distance between the proximal median vertex and the distal median vertex is substantially the same in the collapsed configuration and the expanded configuration of the stent.

15. The transcatheter stent of claim 13, wherein the valve comprises leaflets composed of a non-stretching material.

16. The transcatheter stent of claim 11, wherein the stent is made from one of the following materials or alloys thereof:

cobalt, titanium, nickel, chromium, stainless steel, or combinations thereof.

17. The transcatheter stent of claim 11, wherein the first annular row has 4 to 24 chevron shaped structures, and the second annular row has 4 to 24 chevron shaped structures.

18. A transcatheter stent comprising:

a stent having a first annular row of a plurality of chevron shaped structures, and a second annular row of a plurality of chevron shaped structures;

wherein the first annular row and the second annular row oppose each other, wherein the plurality of chevron shaped structures of the first and second annular rows each have a first V-shaped structure having a proximal median vertex and a second V-shaped structure having a distal median vertex and the first and second V-shaped structures are connected by a pair of lateral edges to form a closed polygon,

the stent having an inner surface and an outer surface and a collapsed configuration and an expanded configuration; and

a valve attached to the inner surface of the stent at a plurality of attachment points, wherein at least one attachment point of the plurality of attachment points is at the proximal median vertex or the distal median vertex of the first annular row, and wherein at least one attachment point of the plurality of attachment points is at the proximal median vertex or the distal median vertex of the second annular row, the valve further comprising one or more leaflets constructed from at least two layers of a fluoropolymer, wherein the at least two layers are anisotropic with orientations that offset by an angle of at least 10 degrees.