DUAL-FLANGE PROSTHETIC VALVE FRAME

• US 20160051362A1
• Filed: 08/19/2015
• Published: 02/25/2016
• Est. Priority Date: 08/21/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Cooper, Alexander H., Peterson, Matthew A.
• Granted Patent: US 10,058,424 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0052 T-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

Embodiments of prosthetic valve frames for implantation within a native mitral valve can include a main body portion, and first and second radially extending flanges coupled to the main body portion. The flanges can be coupled to the main body such that the flanges are spaced father apart from one another when the main body portion is in a crimped configuration than when the main body portion is in an expanded configuration. Associated delivery systems and methods of delivery are provided.

Claims

1. An implantable prosthetic valve comprising:

a radially collapsible and radially expandable annular main body defining a lumen therethrough;

a first flange coupled to the main body and extending radially away from the main body, the first flange comprising a plurality of radially extending first protrusions;

a second flange coupled to the main body and extending radially away from the main body, the second flange comprising a plurality of radially extending second protrusions; and

a valve member supported within the lumen of the frame;

wherein the first flange and the second flange are closer to one another when the main body is in a radially expanded configuration than when the main body is in a radially collapsed configuration; and

wherein each of the first protrusions and each of the second protrusions comprise a first radial strut coupled to a first node of the main body and extending radially away from the main body, a second radial strut coupled to a second node of the main body and extending radially away from the main body, a first angled strut coupled at an angle to the first radial strut, and a second angled strut coupled at an angle to the second radial strut and coupled to the first angled strut.

2. The implantable prosthetic valve of claim 1, wherein:

the valve member defines an inlet end and an outlet end of the implantable prosthetic valve; and

the first flange and the second flange are coupled to the main body at locations located closer to the inlet end than to the outlet end of the implantable prosthetic valve.

3. The implantable prosthetic valve of claim 1, wherein:

the valve member defines an inlet end and an outlet end of the implantable prosthetic valve; and

the first flange and the second flange are coupled to the main body at locations located closer to the outlet end than to the inlet end of the implantable prosthetic valve.

4. The implantable prosthetic valve of claim 1, wherein:

the distance between the first flange and the second flange when the prosthetic valve is in the radially collapsed configuration is larger than the thickness of the native human mitral valve annulus; and

the distance between the first flange and the second flange when the prosthetic valve is in the radially expanded configuration is smaller than the thickness of the native human mitral valve annulus.

5. The implantable prosthetic valve of claim 1, wherein the first protrusions are angularly offset from the second protrusions.

6. The implantable prosthetic valve of claim 1, wherein:

the main body has a first end and a second end and comprises a network of struts interconnected at a plurality of nodes to form a plurality of open cells;

the first protrusions are coupled to first nodes of the main body at the first end of the main body; and

the second protrusions are coupled to second nodes of the main body which are displaced toward the second end of the main body from the first end of the main body by the smallest increment available.

7. The implantable prosthetic valve of claim 1, wherein:

the main body has a first end and a second end and comprises a network of struts interconnected at a plurality of nodes to form a plurality of open cells;

the first protrusions are coupled to first nodes of the main body at the first end of the main body; and

the second protrusions are coupled to second nodes of the main body, the second nodes being the closest nodes in the network of struts to the first nodes.

8. The implantable prosthetic valve of claim 1, wherein:

the main body has a first end and a second end and comprises a network of struts interconnected at a plurality of nodes to form a plurality of open cells;

the first protrusions are coupled to first nodes of the main body at the first end of the main body; and

the second protrusions are coupled to second nodes of the main body, the first nodes and the second nodes being situated in a single circumferential row of open cells.

9. The implantable prosthetic valve of claim 1, wherein:

the first flange extends radially away from the main body such that an angle between a side of the main body and the first flange is between 70° and

110°

; and

the second flange extends radially away from the main body such that an angle between a side of the main body and the second flange is between 70° and

110°

.

10. The implantable prosthetic valve of claim 1, wherein:

the first flange extends radially away from the main body such that an angle between a side of the main body and the first flange is between 80° and

100°

; and

the second flange extends radially away from the main body such that an angle between a side of the main body and the second flange is between 80° and

100°

.

11. The implantable prosthetic valve of claim 1, wherein:

the first flange extends radially away from the main body such that an angle between a side of the main body and the first flange is 90°

; and

the second flange extends radially away from the main body such that an angle between a side of the main body and the second flange is 90°

.

12. The implantable prosthetic valve of claim 1, wherein the first flange extends radially away from the main body parallel to the second flange.

13. The implantable prosthetic valve of claim 1, wherein the first flange and the second flange extend radially away from the main body in directions converging toward one another such that an angle between the radially extending flanges is less than 10°

.

14. The implantable prosthetic valve of claim 1, wherein the first flange and the second flange extend radially away from the main body in directions diverging away from one another such that an angle between the radially extending flanges is less than 10°

.

15. A method of implanting a prosthetic apparatus at the native mitral valve region of a heart, comprising:

delivering the prosthetic apparatus to the native mitral valve region within a delivery apparatus; and

deploying the prosthetic apparatus from the delivery apparatus;

wherein the prosthetic apparatus comprises a main body, a first flange coupled to the main body and extending radially away from the main body perpendicular to a side of the main body, and a second flange coupled to the main body and extending radially away from the main body perpendicular to the side of the main body; and

wherein deploying the prosthetic apparatus from the delivery apparatus allows the prosthetic apparatus to radially expand, such that a distance between the first flange and the second flange decreases and the first flange and the second flange pinch a native mitral valve annulus between them.

16. The method of claim 15, wherein:

the prosthetic apparatus has an inlet end and an outlet end; and

the first flange and the second flange are coupled to the main body at locations located closer to the inlet end than to the outlet end of the prosthetic apparatus.

17. The method of claim 15, wherein:

the prosthetic apparatus has an inlet end and an outlet end; and

the first flange and the second flange are coupled to the main body at locations located closer to the outlet end than to the inlet end of the prosthetic apparatus.

18. The method of claim 15, wherein:

the main body has a first end and a second end and comprises a network of struts interconnected at a plurality of nodes to form a plurality of open cells;

the first flange is coupled to first nodes of the main body at the first end of the main body; and

the second flange is coupled to second nodes of the main body which are displaced toward the second end of the main body from the first end of the main body by the smallest increment available.

19. The method of claim 15, wherein:

the main body has a first end and a second end and comprises a network of struts interconnected at a plurality of nodes to form a plurality of open cells;

the first flange is coupled to first nodes of the main body at the first end of the main body; and

the second flange is coupled to second nodes of the main body, the second nodes being the closest nodes in the network of struts to the first nodes.

20. The method of claim 15, wherein:

the main body has a first end and a second end and comprises a network of struts interconnected at a plurality of nodes to form a plurality of open cells;

the first flange is coupled to first nodes of the main body at the first end of the main body; and

the second flange is coupled to second nodes of the main body, the first nodes and the second nodes being situated in a single circumferential row of open cells.