Stented prosthetic heart valve with variable stiffness and methods of use

• US 9,750,603 B2
• Filed: 01/27/2014
• Issued: 09/05/2017
• Est. Priority Date: 01/27/2014
• Status: Active Grant

• Current Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Original Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Inventors: Bell, Rodney, Costello, Declan
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US14/164,301
• Publication Number:
  US 20150209140A1
• Time in Patent Office: 1,317 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A prosthetic heart valve including a stent frame and a valve structure. The valve structure is disposed within a lumen of the stent frame. The stent frame is configured to self-expand from a compressed condition for transluminal delivery. The stent frame has a lattice structure forming a tubular shape defining a circumference and a plurality of closed cells arranged to define a band exhibiting a variable radial stiffness. The prosthesis can be deployed such that the band applies a minimal force on to anatomical locations relating to the heart'"'"'s conductive pathways. A region of the band otherwise having low radial stiffness is located at or over a conductive pathway upon final implant.

Claims

1. A prosthetic heart valve comprising:

a stent frame configured to be expandable from a compressed condition for transluminal delivery to a natural, expanded condition, the stent frame having a lattice structure forming a tubular shape defining a circumference, wherein the lattice structure provides a plurality of closed cells arranged to define a plurality of bands including a first band of closed cells extending about an entirety of the circumference, each of the closed cells of the first band being uniformly spaced along the circumference, and further wherein the first band is configured to have a variable radial stiffness along the circumference in the natural condition;

wherein the first band defines a first region having at least two circumferentially adjacent closed cells and a second region having a plurality of circumferentially adjacent closed cells, and further wherein a maximum radial stiffness of the first region is less than a minimum radial stiffness of the second region; and

a valve structure disposed within a lumen of the stent frame.

2. The prosthetic heart valve of claim 1, wherein the valve structure includes a plurality of leaflets arranged to define an inflow side and an outflow side, and further wherein the first band is formed proximate the inflow side.

3. The prosthetic heart valve of claim 1, wherein the first region is configured for alignment over conduction fibers of a left ventricular septum.

4. The prosthetic heart valve of claim 1, wherein an arc angle of the first region is less than an arc angle of the second region.

5. The prosthetic heart valve of claim 1, wherein the second region encompasses at least a majority of the circumference.

6. The prosthetic heart valve of claim 1, wherein each of the closed cells includes a plurality of interconnected struts, and further wherein a geometry of at least one of the struts of the closed cells of the first region is less than a corresponding geometry of a corresponding strut of the closed cells of the second region.

7. The prosthetic heart valve of claim 6, wherein the geometry is a length of a segment of the strut.

8. The prosthetic heart valve of claim 6, wherein the geometry is a width of a segment of the strut.

9. The prosthetic heart valve of claim 6, wherein at least one of the struts at the first region is tapered resulting in a variance in mass of the tapered strut as compared to struts at the second region.

10. The prosthetic heart valve of claim 1, wherein the first band further includes a joint connector connecting immediately circumferentially adjacent ones of the closed cells to one another, and further wherein a geometry of each of the joint connectors of the first region is less than a corresponding geometry of each of the joint connectors of the second region.

11. The prosthetic heart valve of claim 10, wherein the geometry is a width of the joint connector.

12. The prosthetic heart valve of claim 1, wherein the first band further includes a third region having at least one closed cell, and further wherein the third region is circumferentially located between the first and second regions, and even further wherein the radial stiffness of the first band along the third region is less than the radial stiffness along the second region and is greater than the radial stiffness along the first region.

13. The prosthetic heart valve of claim 12, wherein the first band further includes a fourth region having at least one close cell, the fourth region being circumferentially located between the first and second regions opposite the third region, and further wherein the radial stiffness of the first band along the fourth region approximates the radial stiffness along the third region.

14. The prosthetic heart valve of claim 1, wherein the plurality of closed cells are arranged to further define a second band of closed cells extending about an entirety of the circumference, the second band being immediately longitudinally adjacent the first band, and further wherein the second band is configured to have a variable radial stiffness along the circumference in the natural condition.

15. The prosthetic heart valve of claim 14, wherein the first and second bands collectively define a low radial stiffness region.

16. The prosthetic heart valve of claim 1, wherein the plurality of closed cells are arranged to further define a second band of closed cells extending about an entirety of the circumference, the second band being immediately longitudinally adjacent the first band, and further wherein the second band is configured to have a constant radial stiffness along the circumference.

17. The prosthetic heart valve of claim 1, wherein the stent frame has first and second ends;

wherein each of the cells of the first band are positioned at an equal distance from the first end of the stent frame.

18. The prosthetic heart valve of claim 1, wherein the first region is adjacent the second region about a single circumference of the stent frame.

19. The prosthetic heart valve of claim 1, wherein the plurality of closed cells are formed by struts and interconnected with nodes extending between adjacent cells, and further wherein the nodes of the first band are configured to have a variance in mass to result in a variable radial stiffness along the circumference in the natural condition.

20. A prosthetic heart valve comprising:

a stent frame configured to expand from a compressed condition for transluminal delivery to a natural, expanded condition, the stent frame having a first end, a second end, and a lattice structure forming a tubular shape defining a circumference, wherein the lattice structure provides a plurality of closed cells arranged to define first and second bands of closed cells each extending about an entirety of the circumference, the first band located immediately longitudinally adjacent the second band, and further wherein the first band is configured to have a variable radial stiffness along the circumference in the natural condition, and even further wherein each of the closed cells of the second band are directly connected to a corresponding one of the closed cells of the second band;

wherein each of the cells of the first band are positioned at an equal distance from the first end of the stent frame;

further wherein each of the closed cells includes a plurality of interconnected struts, and at least one of the struts of the first band has a tapered shape; and

a valve structure disposed within a lumen of the stent frame.

21. The prosthetic heart valve of claim 20, wherein the first band defines a first region and a second region;

wherein the plurality of closed cells are interconnected at nodes and at least one node of the first region is configured to have a first mass and the nodes of the second region are configured to have a second mass;

wherein the first mass is less than the second mass.