Valve prosthesis

• US 9,999,501 B2
• Filed: 04/18/2012
• Issued: 06/19/2018
• Est. Priority Date: 04/18/2012
• Status: Active Grant

• Current Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Inventors: Punga, Karan, Rinne, Finn, Barrett, Donna
• Primary Examiner(s): Prebilic, Paul
• Application Number:
  US13/449,863
• Publication Number:
  US 20130282113A1
• Time in Patent Office: 2,253 Days
• Field of Search: 623 124, 623 126, 623 212- 219, 623900
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

Heart valve prostheses are provided having a self-expanding frame that supports a valve body comprising a skirt and a plurality of coapting leaflets. The self-expanding frame includes an inflow section, a valve section, and an outflow section. The outflow section forms attachment loops in a collapsed configuration to attach the frame to a delivery system.

Claims

1. A valve prosthesis comprising:

a valve body including a plurality of valve leaflets affixed to a skirt; and

a frame including a distal inflow section, a proximal outflow section, and a valve section between the inflow section and the outflow section, wherein;

the valve body is attached to the frame in the valve section at a plurality of commissure points,

the frame includes a circumferentially repeating cell pattern in the inflow section and the valve section,

the outflow section includes a plurality of loops, the plurality of loops being attached to a proximal row of circumferentially repeating cells of the valve section at a plurality of junctions,

wherein each of the plurality of loops includes a respective first strut and a respective second strut joined proximally at a loop edge, with the first strut being attached distally to a proximal crown of a respective first cell of the proximal row of cells of the valve section at a respective first junction of the plurality of junctions and with the second strut being attached distally to a proximal crown of a respective second cell of the proximal row of cells of the valve section at a respective second junction of the plurality of junctions,

wherein a plurality of circumferentially adjacent cells in the proximal row of cells of the valve section are positioned entirely between the first and second junctions of each loop in a circumferential direction, with proximal crowns of the plurality of circumferentially adjacent cells being unattached to the outflow section, and

wherein the valve section is distal to the outflow section and a proximal-most end of the commissure points is distal to the proximal crowns of the plurality of circumferentially adjacent cells of the proximal row of cells.

2. The valve prosthesis of claim 1, wherein the plurality of loops includes a first loop, a second loop and a third loop,

wherein the first junction of the first loop corresponds to the second junction of the second loop such that the first loop and the second loop are connected to the proximal row of cells of the valve section at a first common crown of the proximal row of cells of the valve section that is the crown of first cell corresponding to the first loop and the second cell corresponding to the second loop, and

wherein the first junction of the second loop corresponds to the second junction of the third loop such that the second loop and the third loop are connected to the proximal row of cells of the valve section at a second common crown of the proximal row of cells of the valve section that is the crown of the first cell corresponding to the second loop and the second cell corresponding to the third loop.

4. The valve prosthesis of claim 1, wherein the plurality of circumferentially adjacent cells in the proximal row of cells of the valve section is two valve section cells being positioned between the first and second junctions of each loop in a circumferential direction.

3. A valve prosthesis comprising:

a valve body including a plurality of valve leaflets affixed to a skirt; and

a frame including a distal inflow section, a proximal outflow section, and a valve section between the inflow section and the outflow section, wherein;

the valve body is attached to the frame in the valve section at a plurality of commissure points,

the frame includes a circumferentially repeating cell pattern in the inflow section and the valve section,

the outflow section includes a plurality of loops, the plurality of loops being attached to a proximal row of circumferentially repeating cells of the valve section at a plurality of junctions,

wherein each of the plurality of loops includes a respective first strut and a respective second strut joined proximally at a loop edge, with the first strut being attached distally to a proximal crown of a respective first cell of the proximal row of cells of the valve section at a respective first junction of the plurality of junctions and with the second strut being attached distally to a proximal crown of a respective second cell of the proximal row of cells of the valve section at a respective second junction of the plurality of junctions,

wherein a plurality of circumferentially adjacent cells in the proximal row of cells of the valve section are positioned entirely between each of the first and second junctions of a respective loop in a circumferential direction with proximal crowns of the plurality of circumferentially adjacent cells being unattached to the outflow section, and

wherein in a collapsed configuration of the frame, a portion of the first strut of each loop touches a portion of the second strut of the respective loop to form a closed attachment loop between the first strut, the second strut, and the loop edge of each respective loop, and wherein the portions of the first strut and the second strut which touch each other in the collapsed configuration do not touch each other in a deployed configuration of the frame.

5. The valve prosthesis of claim 3, wherein:

the first strut of each of the plurality of loops includes a first concave curve and the second strut of each of the plurality of loops includes a second concave curve, and

in the collapsed configuration, the first concave curve of each loop touches the second concave curve of the respective loop.

6. The valve prosthesis of claim 3, wherein the closed attachment loop is configured to surround and engage an attachment tab on a valve prosthesis delivery system.

7. A valve prosthesis for deploying within a native aortic heart valve comprising:

a valve body including a plurality of leaflets affixed to a skirt; and

a single lumen frame including,

a first tubular structure having a first axis,

a second tubular structure having a second axis, the second tubular structure including a plurality of loops wherein each of the plurality of loops includes a first strut and a second strut joined proximally at a loop edge and joined distally to respective first and second junctions of a plurality of junctions that attach the first tubular structure to the second tubular structure, the plurality of junctions forming bending points between the first tubular structure and the second tubular structure,

wherein in a collapsed configuration of the frame, the first strut and the second strut of each loop each includes four curves, a first curve, a second curve, a third curve, and a fourth curve, wherein the first curve is disposed between one of the first and second junctions and the second curve, the second curve is disposed between the first curve and the third curve, the third curve is disposed between the second curve and the fourth curve, and the fourth curve is disposed between the third curve and the loop edge,

wherein the third curve of each of the first strut and the second strut of one of the plurality of loops touch each other when the frame is in the collapsed configuration and do not touch each other in a deployed configuration of the frame,

wherein the valve body is attached to the frame in the first tubular structure, and

wherein in the deployed configuration the second tubular structure is configured to bend from the first tubular structure at the plurality of junctions such that the first axis of the first tubular structure generally aligns on a sinus axis of a native aortic heart valve and the second axis of the second tubular structure generally aligns on an aortic axis of an aorta with the second axis being offset at an angle from the first axis.

8. The valve prosthesis of claim 7, wherein the first tubular structure is substantially rigid.

9. The valve prosthesis of claim 7, wherein

the plurality of leaflets are attached to the first tubular structure at a plurality of commissure points, and

the first tubular structure is distal to the second tubular structure and the plurality of commissure points are distal to the plurality of junctions.

10. The valve prosthesis of claim 7, wherein deformation of the second tubular structure does not substantially deform the first tubular structure.

11. The valve prosthesis of claim 7, wherein

the plurality of loops includes a first loop, a second loop, and a third loop,

the first junction of the first loop corresponds to the second junction of the second loop such that the first strut of the first loop and the second strut of the second loop are connected to the first tubular structure at a first crown of an edge of the first tubular structure, and

the first junction of the second loop corresponds to the second junction of the third loop such that the first strut of the second loop and the second strut of the third loop are connected to the first tubular structure at a second crown of the edge of the first tubular structure.

12. The valve prosthesis of claim 7, wherein each loop is configured to surround and engage an attachment tab on a valve prosthesis delivery system with the frame in the collapsed configuration.

13. The valve prosthesis of claim 7, wherein the second tubular structure includes at least four loops.

14. The valve prosthesis of claim 7, wherein the first curve and the third curve are curved in a first direction and the second curve and the fourth curve are curved in a second direction generally opposite the first direction.

15. The valve prosthesis of claim 7, wherein the second curve of the first strut of a first one of the plurality of loops touches the second curve of the second strut of an adjacent one of the plurality of loops.