Stents, valved-stents and methods and systems for delivery thereof

• US 9,839,513 B2
• Filed: 08/19/2016
• Issued: 12/12/2017
• Est. Priority Date: 10/25/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Symetis SA (Boston Scientific Corporation)
• Inventors: Essinger, Jacques, Delaloye, Serge, Hefti, Jean-Luc, Delaloye, Stephane
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US15/241,985
• Publication Number:
  US 20160354205A1
• Time in Patent Office: 480 Days
• Field of Search: 623 21- 219
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Embodiments of the present disclosure are directed to stents, valved-stents, (e.g., single-stent-valves and double stent/valved-stent systems) and associated methods and systems for their delivery via minimally-invasive surgery. The stent component comprises a first stent section (102) a second stent section (104) a third stent section (106) and a fourth stent section (108).

Claims

1. A replacement valve for use within a human body comprising:

a stent component comprising a first end and a second end and a plurality of sections including;

a first stent section defining an at least partly conical body, wherein the first stent section defines the proximal end of the stent component;

a second stent section in communication with the first stent section and defining an at least partly conical body, wherein the conical body of the first stent section slopes outwardly in the direction of the first end, and wherein the conical body of the second stent section slopes outwardly in the direction of the second end;

a distal stent section comprising

a third stent section in communication with the second stent section and housing at least a portion of a valve component of the replacement valve, and

a fourth stent section defining an at least partly conical body, wherein the fourth stent section defines the second end and comprises valve stabilization arches for orienting the replacement valve longitudinally within an aorta/aortic annulus for preventing tilting of the replacement valve when implanted;

wherein each valve stabilization arch has a first end in communication with the third section, a second end in communication with the third section, and an apex at the second end of the stent component.

2. A replacement valve for use within a human body comprising:

a stent component comprising a first end and a second end, the stent component further comprising a plurality of sections including;

a first stent section defining an at least partly conical body, wherein the first stent section defines the proximal end of the stent component;

a second stent section in communication with the first stent section and defining an at least partly conical body, wherein the conical body of the first stent section slopes outwardly in the direction of the first end, and wherein the conical body of the second stent section slopes outwardly in the direction of the second end;

a distal stent section comprising

a third stent section in communication with the second stent section and housing at least a portion of a valve component of the valve component of the replacement valve, and

a fourth stent section defining an at least partly conical body, wherein the fourth stent section defines the second end and comprises exactly three valve stabilization arches for orienting the replacement valve longitudinally within an aorta/aortic annulus for preventing tilting of the replacement valve when implanted.

3. The replacement valve of claim 2, wherein the first stent section comprises an anchoring crown, and wherein tips of elements forming the anchoring crown of the second stent section are bent towards the longitudinal axis of the stent.

4. The replacement valve of claim 2, wherein the third section comprises at least a partially cylindrical body.

5. The replacement valve of claim 4, wherein the third stent section comprises valve fixation arches.

6. The replacement valve of claim 5, wherein the at least partially cylindrical body of the third stent section comprises valve fixation elements.

7. The replacement valve of claim 2, wherein the conical body of the first stent section slopes outwardly from an inner diameter D2 to an outer diameter D3 in the direction of the first end, wherein the inner diameter D2 is between about 20 mm to about 30 mm, and wherein the outer diameter D3 is between about 22 mm to about 40 mm.

8. The replacement valve of claim 7, wherein the axial distance between the planes of diameters D2 and D3 in an expanded configuration is between about 3 to about 15 mm.

9. The replacement valve of claim 7, wherein the outward slope of the first stent section is defined by an angle α

2, and wherein α

2 is between from about 5 degrees to about 50 degrees.

10. The replacement valve of claim 2, wherein the conical body of the second stent section slopes outwardly from an inner diameter D2 to an outer diameter D1 in the direction of the second end, wherein the inner diameter D2 is between about 20 mm to about 30 mm, and wherein the outer diameter D1 is between about 22 mm to about 40 mm.

11. The replacement valve of claim 10, wherein the axial distance between the planes of the diameters D2 and D1 in an expanded configuration is about 3 mm to about 10 mm.

12. The replacement valve of claim 10, wherein the outward slope of the second stent section is defined by an angle α

1, and wherein α

1 is between from about 10 degrees to about 80 degrees.

13. The replacement valve of claim 2, wherein the end of the second stent section forms a tip, and wherein the tip is bent inwardly toward the longitudinal axis at an angle α

3, and wherein α

3 is between from about 0 degrees to about 180 degrees.

14. The replacement valve of claim 5, wherein the length of the combined second section and third section of the stent component is between about 3 mm to about 50 mm.

15. The replacement valve of claim 5, wherein the length of the fourth section is between about 5 mm to about 50 mm.

16. The replacement valve of claim 2, wherein angle α

4 represents an offset angle from a longitudinal axis of the stabilization arches of the stent in an expanded configuration, wherein the stabilization arches expand outwardly at angle α

4 from a longitudinal axis toward the second distal end of the replacement valve, and wherein α

4 is between about 0 degrees to about 60 degrees.

17. The replacement valve of claim 2, wherein angle α

5 represents an offset angle from a longitudinal axis of the stabilization arches of the stent in the expanded configuration, wherein the stabilization arches expand inwardly at angle α

5 from a longitudinal axis toward the second distal end of the replacement valve, and wherein α

5 is between about 0 degrees to about 20 degrees.

18. The replacement valve of claim 2, further comprising attachment elements at the first end, wherein the attachment elements are used to removably attach the stent component to a delivery device.

19. The replacement valve of claim 2, wherein the fourth stent section defines the at least partially conical body when only partially deployed and devise at least partially cylindrical body when in a deployed state.

20. The replacement valve of claim 2, wherein the second stent section is configured to create a form fit with an outflow tract and native leaflets of an aortic valve and thus prevent migration of the stent component and the valve component towards the left ventricle.