IP Library › Granted Patent US 12702550

Granted Patent B2

US 12702550 · App. 18/480,194 · Granted Aug 11, 2026

Stent and replacement heart valve prosthesis with improved fixation features

Inventors: Georg Rahmig (Pforzheim, DE); Helmut Straubinger (Aschheim, DE); Coralie Marchand (Munich, DE)

Assignee: TRICARES SAS

A61F2/2418 A61F2/2427 A61F2/848 A61F2/91 A61F2/9522 A61F2210/0014 A61F2210/0076 A61F2220/0033 A61F2220/0041 A61F2220/0058 A61F2220/0075 A61F2230/001 A61F2250/0039

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Quick Facts

Patent No.: US 12702550
App. No.: 18/480,194
Granted: Aug 11, 2026
Kind: B2

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Abstract

The present invention relates to an improved stent and a replacement heart valve prosthesis exhibiting improved fixation features.

Claims (49)

1 . A heart valve prosthesis, comprising:

an inner stent carrying a replacement heart valve, the inner stent having an inner proximal area and an inner distal area; and

an outer stent having an outer proximal area, an outer distal area, and a middle area between the outer proximal area and the outer distal area, wherein each of the outer proximal area and the outer distal area has a diameter greater than a diameter of the middle area, forming a groove at the middle area, the groove configured to support fixation of the outer stent at an annulus of an endogenous heart valve,

wherein the outer stent is radially outward of the inner stent to form an annular space between the inner stent and the outer stent,

wherein the inner stent includes (1) inner connecting struts and (2) all other inner stent structure other than the inner connecting struts, each inner connecting strut having a free point of connection unconnected to the all other inner stent structure,

wherein the outer stent includes (1) outer connecting struts and (2) all other outer stent structure other than the outer connecting struts, each outer connecting strut having (a) a first end connected to the all other outer stent structure between a proximalmost end and a distalmost end of the outer stent, and spaced apart from the proximalmost end and the distalmost end of the outer stent, and (b) a free point of connection unconnected to the all other outer stent structure, proximal of the first end, and between the proximalmost end and the distalmost end of the outer stent,

wherein the free point of connection of each inner connecting strut of the inner connecting struts is fixed to the free point of connection of a corresponding outer connecting strut of the outer connecting struts, to connect the inner stent to the outer stent,

wherein the proximalmost end of the outer stent is proximal of a proximalmost end of the inner stent,

wherein the only portions of the inner stent and the outer stent that are within the annular space are one or both of the inner connecting struts and the outer connecting struts, and

wherein the free point of connection of each inner connecting strut is at the proximalmost end of the inner stent and proximal of the all other inner stent structure.

2 . The heart valve prosthesis of claim 1 , wherein the only portions of the inner stent and the outer stent that are within the annular space are the inner connecting struts and the outer connecting struts.

3 . The heart valve prosthesis of claim 1 , wherein the distalmost end of the outer stent is spaced from the inner stent by the annular space.

4 . The heart valve prosthesis of claim 1 , wherein a rivet, glue, a weld, a clip, a screw, or a suture connects each inner connecting strut of the inner connecting struts to the corresponding outer connecting strut of the outer connecting struts.

5 . The heart valve prosthesis of claim 1 , wherein the outer stent includes a plurality of anchors distally of the groove and protruding radially outward of cells of the outer stent,

wherein the anchors support fixation of the outer stent at an implantation site, and

wherein the anchors are integral parts of the outer stent.

6 . The heart valve prosthesis of claim 5 , wherein each anchor of the plurality of anchors has a length of 2 mm to 15 mm.

7 . The heart valve prosthesis of claim 1 , wherein each of the inner stent and the outer stent is a laser cut stent.

8 . The heart valve prosthesis of claim 1 , wherein the inner stent includes two to six rows of cells.

9 . The heart valve prosthesis of claim 1 , wherein the inner connecting struts include 8 to 18 inner connecting struts, and the outer connecting struts include 8 to 18 outer connecting struts.

10 . The heart valve prosthesis of claim 1 , wherein each of the inner stent and the outer stent is made of nitinol.

11 . The heart valve prosthesis of claim 1 , wherein the inner stent has a round shape, the replacement heart valve includes exactly three leaflets, and the replacement heart valve is fixed to the inner stent by sutures.

12 . The heart valve prosthesis of claim 1 , wherein at least a portion of one or both of the inner connecting struts and the outer connecting struts is at a same axial location as the groove.

13 . The heart valve prosthesis of claim 1 , wherein the outer distal area includes a distalmost end having a diameter less than a diameter of an area of the outer distal area that is proximal of the distalmost end.

14 . The heart valve prosthesis of claim 1 , wherein no portion of the inner stent and no portion of the outer stent is radially outward of the groove.

15 . The heart valve prosthesis of claim 1 , wherein the inner stent and the outer stent have a low profile configuration for delivery to the endogenous heart valve via a catheter, and wherein the inner stent and the outer stent expand from the low profile configuration to an expanded configuration during deployment, and wherein at least a portion of the outer stent is radially outward of the inner stent when the inner stent and the outer stent have the low profile configuration for delivery.

16 . A heart valve prosthesis, comprising:

an inner stent carrying a replacement heart valve, the inner stent having an inner proximal area and an inner distal area; and

wherein the outer stent is radially outward of the inner stent to form an annular space between the inner stent and the outer stent,

wherein the outer stent includes (1) outer connecting struts and (2) all other outer stent structure other than the outer connecting struts, each outer connecting strut having (a) a first end connected to the all other outer stent structure between a proximalmost end and a distalmost end of the outer stent, and (b) a free point of connection unconnected to the all other outer stent structure, proximal of the first end, and between the proximalmost end and the distalmost end of the outer stent,

wherein the proximalmost end of the outer stent is proximal of a proximalmost end of the inner stent,

wherein the only portions of the inner stent and the outer stent that are within the annular space are one or both of the inner connecting struts and the outer connecting struts, and

wherein the free point of connection of each inner connecting strut is at the proximalmost end of the inner stent, proximal of the all other inner stent structure, and radially outward of the all other inner stent structure.

17 . The heart valve prosthesis of claim 16 , wherein the free point of connection of the inner stent is at substantially a same axial location as the groove.

18 . A heart valve prosthesis, comprising:

an inner stent carrying a replacement heart valve, the inner stent having an inner proximal area and an inner distal area; and

wherein the outer stent is radially outward of the inner stent to form an annular space between the inner stent and the outer stent,

wherein the inner stent includes (1) inner connecting struts and (2) all other inner stent structure other than the inner connecting struts, each inner connecting strut having a connecting end unconnected to the all other inner stent structure,

wherein the outer stent includes (1) outer connecting struts and (2) all other outer stent structure other than the outer connecting struts, each outer connecting strut having (a) a first end connected to the all other outer stent structure between a proximalmost end and a distalmost end of the outer stent, and (b) a connecting end unconnected to the all other outer stent structure, proximal of the first end, and between the proximalmost end and the distalmost end of the outer stent,

wherein the connecting end of each inner connecting strut of the inner connecting struts is fixed to the connecting end of a corresponding outer connecting strut of the outer connecting struts, to connect the inner stent to the outer stent,

wherein the proximalmost end of the outer stent is proximal of a proximalmost end of the inner stent,

wherein the only portions of the inner stent and the outer stent that are within the annular space are one or both of the inner connecting struts and the outer connecting struts,

wherein the connecting end of each inner connecting strut is at the proximalmost end of the inner stent and proximal of the all other inner stent structure, and

wherein at least one of i) the connecting end of each inner connecting strut is wider than other portions of the inner connecting strut, or ii) the connecting end of each outer connecting strut is wider than other portions of the outer connecting strut.

19 . The heart valve prosthesis of claim 18 , wherein at least one of i) the connecting end of each inner connecting strut is wider than all remaining portions of the inner connecting strut, or ii) the connecting end of each outer connecting strut is wider than all remaining portions of the outer connecting strut.