Heart valve prosthesis

• US 10,682,226 B2
• Filed: 04/06/2017
• Issued: 06/16/2020
• Est. Priority Date: 04/11/2016
• Status: Active Grant

• Current Assignee: Biotronik AG (Biotronik SE & Company KG)
• Original Assignee: Biotronik AG (Biotronik SE & Company KG)
• Inventors: Ulmer, Jens, Degen, Nicolas
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US15/480,974
• Publication Number:
  US 20170290659A1
• Time in Patent Office: 1,167 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2250/0036 differing in thickness

Abstract

A heart valve prosthesis (1), including: a stent framework (2), which can be transferred from a collapsed state into an expanded state, in which the stent framework (2) extends along an axis (A′), wherein the stent framework (2) has a plurality of struts (20, 24), which form a plurality of cells (21a, 21b, 25) connected to one another; and a heart valve (3), which is fixed to the stent framework (2). In accordance with the invention, the thickness (d′) of the struts varies in the peripheral direction (U) of the expanded stent framework (2).

Claims

1. A heart valve prosthesis, comprising:

a stent framework that extends along an axis and which can be transferred from a collapsed state into an expanded state that when implanted has a D-shaped cross-sectional contour comprising a flattened portion that extends from a region of a left fibrous trigone to a region of a right fibrous trigone and an arcuate portion connected thereto, wherein the stent framework has a plurality of struts, which form a plurality of cells connected to one another, and

a heart valve, which is secured to the stent framework,

characterized in that first struts configured to lie in the region of a left fibrous trigone and in the region of the right fibrous trigone have a smaller thickness than second struts of the stent framework configured to lie on a mitral valve annulus, wherein the first struts provide opposing ends of the flattened portion when in the implanted and expanded state.

2. The heart valve prosthesis according to claim 1, characterized in that the heart valve prosthesis is configured to take on a function of a native mitral valve, wherein the heart valve of the heart valve prosthesis is a mitral valve.

3. The heart valve prosthesis according to claim 1, characterized in that the thicknesses of the struts vary in the peripheral direction, in such a way that the stent framework in the expanded and implanted state has a peripheral cross-sectional contour which is adapted to the mitral valve annulus of the mitral valve that is to be replaced.

4. The heart valve prosthesis according to claim 1, characterized in that the first struts have a thickness which is 0.5 times to 0.9 times the thickness of the second struts.

5. The heart valve prosthesis according to claim 1, characterized in that the first struts form two cells of the stent framework, which are arranged adjacently in a direction of the axis and are connected to one another via a connection region, wherein the two cells come to lie in the region of the left fibrous trigone, based on the expanded and implanted state of the stent framework.

6. The heart valve prosthesis according to claim 5, characterized in that the connection region has a first and a second edge portion, wherein the two edge portions lie opposite one another in the peripheral direction, wherein a recess is formed in each edge portion, and wherein the two recesses are arranged offset relative to one another in the direction of the axis.

7. The heart valve prosthesis according to claim 1, characterized in that the first struts form two further cells of the stent framework, which are arranged adjacently in a direction of the axis and are connected to one another via a further connection region, wherein the two further cells come to lie in the region of the right fibrous trigone, based on the expanded and implanted state of the stent framework.

8. The heart valve prosthesis according to claim 7, characterized in that the further connection region has a first and a second edge portion, wherein the two edge portions lie opposite one another in the peripheral direction, wherein a recess is formed in each edge portion, and wherein the two recesses are arranged offset relative to one another in the direction of the axis.

9. The heart valve prosthesis according to claim 1, characterized in that the stent framework, in order to allow blood to flow out, defines an outflow tract, wherein the stent framework at the outflow tract has loops for anchoring the heart valve prosthesis at anterior and posterior cusps of a native mitral valve.

10. The heart valve prosthesis according to claim 9, wherein two anterior loops are provided, which are configured to anchor the heart valve prosthesis at the anterior cusp of the native mitral valve, and a posterior loop is configured to anchor the heart valve prosthesis at the posterior cusp of the native mitral valve, further wherein the posterior loop is shorter than the two anterior loops for the anterior cusp.

11. The heart valve prosthesis according to claim 1, characterized in that the stent framework has cells at an outflow tract for anchoring the heart valve prosthesis, wherein the cells are curved outwardly.

12. The heart valve prosthesis according to claim 1, characterized in that the stent framework has shortened cells on a peripheral edge of an inflow tract of the stent framework, wherein the length of the shortened cells is shorter in a direction of the axis than the length of peripheral cells that are adjacent in the peripheral direction, wherein the shortened cells are configured to come to lie in a region of an aortic peak of a native mitral valve in the expanded and implanted state of the stent framework.

13. The heart valve prosthesis according to claim 1, characterized in that the stent framework is expandable.

14. The heart valve prosthesis according to claim 1, characterized in that the heart valve prosthesis is configured to be implanted by means of a catheter.

15. The heart valve prosthesis according to claim 1, wherein a same stent framework is configured to expand to adopt two different expanded configurations, wherein a first expanded configuration comprises a circular cross-section and a second expanded configuration comprises the D-shaped cross-sectional contour, wherein the two different configurations are determined by forces acting against the stent framework.

16. The heart valve prosthesis according to claim 1, wherein the thickness of the first struts is 0.8 times the thickness of the second struts.

17. The heart valve prosthesis according to claim 1, characterized in that the stent framework is self-expanding.

18. The heart valve prosthesis according to claim 1, wherein the stent framework is not pre-set to form the D-shaped cross-sectional contour upon expansion.