HYBRID ORIENTATION PARAVALVULAR SEALING STENT

• US 20160158004A1
• Filed: 06/27/2014
• Published: 06/09/2016
• Est. Priority Date: 07/01/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Kumar, Saravana B., Khouengboua, Sounthara
• Granted Patent: US 10,117,743 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0057 stretchable
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• 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
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers

Abstract

A prosthetic heart valve (300) for replacing a native heart valve includes a collapsible and expandable stent (306) extending in a length direction between a proximal end (302) and a distal end (304), the stent (306) including a plurality of struts (320) defining a plurality of cells (330), the plurality of cells (330) forming an aortic section (310), an annulus section (314) and a subannular section (316) of the stent (306). A valve assembly is disposed within the annulus section (314) of the stent (306), the valve assembly including a plurality of leaflets. In an expanded condition of the stent, each of the plurality of cells of the subannular section (316) has a width greater than its length, and each of the plurality of cells of the annulus section (314) has a length greater than its width.

Claims

1. A prosthetic heart valve for replacing a native valve, comprising:

a collapsible and expandable stent extending in a length direction between a proximal end and a distal end, the stent including a plurality of struts defining a plurality of cells, the plurality of cells forming an aortic section, an annulus section and a subannular section of the stent, each of the cells having a length in the length direction and a width in a circumferential direction of the stent; and

a valve assembly disposed within the annulus section of the stent, the valve assembly including a plurality of leaflets;

wherein, in an expanded condition of the stent, each of the plurality of cells of the subannular section has a width greater than its length, and each of the plurality of cells of the annulus section had a length greater than its width.

2. The prosthetic heart valve of claim 1, wherein the plurality of cells include a plurality of mitre-shaped transition cells disposed between the annulus section and the subannular section.

3. The prosthetic heart valve of claim 1, wherein the plurality of cells of the subannular section in the expanded condition are generally oval-shaped with upper and lower peaks.

4. The prosthetic heart valve of claim 1, wherein the struts of the subannular section have an average thickness less than an average thickness of the struts of the annulus section.

5. The prosthetic heart valve of claim 1, wherein the struts of the subannular section have an average thickness between about ⅓

to about ½

of an average thickness of struts of the annulus section.

6. The prosthetic heart valve of claim 1, wherein the subannular section is configured and arranged to be disposed below leaflets of the native valve when the prosthetic valve replaces the native valve.

7. A prosthetic heart valve for replacing a native valve, comprising:

a collapsible and expandable stent having a proximal end, a distal end, and a plurality of struts defining a plurality of cells, the plurality of cells forming an aortic section, an annulus section and a subannular section of the stent; and

a valve assembly disposed within the annulus section of the stent, the valve assembly including a plurality of leaflets,

wherein the struts of the annulus section have a first average thickness and the struts of the subannular section have a second average thickness different from the first average thickness.

8. The prosthetic heart valve of claim 7, wherein the second average thickness is less than the first average thickness.

9. The prosthetic heart valve of claim 7, wherein the second average thickness is between about ⅓

to about ½

of the first average thickness.

10. A prosthetic heart valve for replacing a native valve, comprising:

a collapsible and expandable stent extending in a length direction between a proximal end and a distal end, the stent including a plurality of struts defining a plurality of cells, the plurality of cells forming an aortic section, an annulus section and a subannular section of the stent; and

a valve assembly disposed within the annulus section of the stent, the valve assembly including a plurality of leaflets,

wherein the subannular section in an expanded condition of the stent has a larger diameter than the annulus section in the expanded condition of the stent.

11. The prosthetic heart valve of claim 10, wherein the subannular section in the expanded condition of the stent has a diameter between about 2 mm and about 6 mm larger than a diameter of the annulus section in the expanded condition of the stent.

12. The prosthetic heart valve of claim 10, wherein each of the plurality of cells has a length in the length direction and a width in a circumferential direction of the stent, and for each of the plurality of cells of the subannular section the length is less than the width in the expanded condition.

13. The prosthetic heart valve of claim 10, wherein each of the plurality of cells has a length in the length direction and a width in a circumferential direction of the stent, and for each of the plurality of cells of the subannular section the length is between about 5 mm and about 12 mm and the width is between about 9 mm and about 16 mm in the expanded condition.

14. A method implanting a prosthetic heart valve comprising:

delivering the prosthetic heart valve in a collapsed condition to the native valve annulus, the heart valve including;

(i) a collapsible and expandable stent extending in a length direction between a proximal end and a distal end and including a plurality of struts defining a plurality of cells, the plurality of cells forming an aortic section, an annulus section and a subannular section of the stent, each of the cells having a length in the length direction and a width in a circumferential direction of the stent, and (ii) a valve assembly disposed within the annulus section of the stent, the valve assembly including a plurality of leaflets;

transitioning the stent from the collapsed condition to an expanded condition, whereby the plurality of cells of the subannular section foreshorten in the length direction by a first relative amount and the plurality of cells of the annulus section foreshorten in the length direction by a second relative amount less than the first relative amount.

15. The method of claim 14, wherein the plurality of cells of the subannular section foreshorten by between about 50% and about 100% and the plurality of cells of the annulus section foreshorten by between about 10% and about 18%.

16. The method of claim 14, wherein the plurality of cells of the subannular section foreshorten between about three times and about five times more than the plurality of cells of the annulus section.

17. The method of claim 14, wherein when the stent transitions from the collapsed condition to the expanded condition, the plurality of cells of the subannular section increase in width by between about 500% and about 1500% and the plurality of cells of the annulus section increase in width by between about 300% and about 1000%.

18. The method of claim 14, wherein when the stent transitions from the collapsed condition to the expanded condition, the plurality of cells of the subannular section increase in width between about 1.6 times and about 1.1 times more than the plurality of cells of the annulus section.