Prosthetic valve for transluminal delivery

• US 8,579,966 B2
• Filed: 02/04/2004
• Issued: 11/12/2013
• Est. Priority Date: 11/17/1999
• Status: Expired due to Term

• Current Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Original Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Inventors: Seguin, Jacques, Brtlein, Georg
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US10/772,101
• Publication Number:
  US 20040210304A1
• Time in Patent Office: 3,569 Days
• Field of Search: 623 112- 242
• US Class Current: 623/2.18
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/93 circumferentially expandable by using ratcheting locks
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0048 : differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0069 : Sealing means

Abstract

A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable contact the anatomical annulus of the native valve when the assembly is properly positioned. Portions of the valve support may expand to a preset diameter to maintain coaptivity of the replacement valve and to prevent occlusion of the coronary ostia.

Claims

1. A prosthetic cardiac valve assembly comprising:

a) a replacement valve comprising;

a plurality of leaflets configured to permit blood to selectively flow therethrough; and

a plurality of commissure points from which the replacement valve is suspended;

b) a valve support connected to the replacement valve and configured to be collapsible for trans luminal delivery,

said valve support having an axial length sufficient to extend, when implanted, from a position of a native annulus, past the replacement valve, past the commissure points, and past the patient'"'"'s coronary ostia, and into an ascending aorta;

wherein outer circumference of the valve support varies along at least some portions of the axial length;

wherein the valve support further comprises;

a first section terminating in a first end, said first end comprising an outer circumference having a first diameter, said first section configured to engage the native annulus; and

a second section terminating in a second end, said second end comprising an outer circumference having a second diameter, said second section configured to extend past the coronary ostia and into the ascending aorta,

wherein the second circumference is greater than the first circumference.

2. The prosthetic cardiac valve assembly of claim 1, wherein said first section comprises a plurality of intersecting members forming a plurality of cells, said cells having a first cross-sectional size and arranged substantially uniformly around a periphery of the valve support;

wherein the second section comprises a plurality of intersecting members forming a plurality of cells, said cells having a second cross-sectional size and arranged substantially uniformly around a periphery of the valve support; and

wherein the second cross-sectional size is greater than the first cross-sectional size.

3. The prosthetic cardiac valve assembly of claim 2, wherein the cells at the first and second sections comprise a diamond shape.

4. The prosthetic cardiac valve assembly of claim 1, wherein the valve support is self-expanding.

5. The prosthetic cardiac valve assembly of claim 1, wherein the valve support comprises a plurality of wires.

6. The prosthetic cardiac valve assembly of claim 1, wherein the valve support comprises a shape memory material.

7. The prosthetic cardiac valve assembly of claim 6, wherein the shape memory material comprises Nitinol.

8. The prosthetic cardiac valve assembly of claim 1, wherein the replacement valve is secured to the valve support using at least one suture.

9. The prosthetic cardiac valve assembly of claim 1, wherein the replacement valve comprises at least three leaflets.

10. The prosthetic cardiac valve assembly of claim 1, wherein at least a portion of the valve support is configured to apply a radial expansion force up to a predetermined diameter.

11. A prosthetic cardiac valve assembly comprising:

a replacement valve comprising a plurality of leaflets and a plurality of commissure points from which the replacement valve is generally suspended; and

a valve support having a proximal portion and a distal portion, said valve support connected to the replacement valve and configured to be collapsible for trans luminal delivery;

wherein the valve support is configured to extend, when implanted into a patient, from a native annulus at the proximal portion to an ascending aorta at the distal portion, past a location of the patient'"'"'s coronary ostia;

wherein an outer shape of the valve support varies along an axial length of said valve support such that a cross-sectional dimension of the distal portion is generally larger than a cross-sectional dimension of the proximal portion;

wherein the valve support comprises a plurality of intersecting members forming a plurality of cells, said cells being arranged substantially uniformly around a periphery of the valve support; and

wherein the plurality of cells located along the distal portion of the valve support have a larger cross-sectional size than the plurality of cells located along the proximal portion of the valve support.

12. The prosthetic cardiac valve assembly of claim 11, wherein the valve support comprises a proximal end and a distal end, a cross-sectional dimension of said distal end being larger than a cross-sectional dimension of said proximal end.

13. The prosthetic cardiac valve assembly of claim 11, wherein the plurality of cells at the proximal and distal portions comprise a diamond shape.

14. The prosthetic cardiac valve assembly of claim 11, wherein the valve support is self-expanding.

15. The prosthetic cardiac valve assembly of claim 11, wherein the valve support comprises a plurality of wires.

16. The prosthetic cardiac valve assembly of claim 11, wherein the valve support comprises a shape memory material.

17. The prosthetic cardiac valve assembly of claim 16, wherein the shape memory material comprises Nitinol.

18. The prosthetic cardiac valve assembly of claim 11, wherein the replacement valve is secured to the valve support using at least one suture.

19. The prosthetic cardiac valve assembly of claim 11, wherein the replacement valve comprises at least three leaflets.

20. The prosthetic cardiac valve assembly of claim 11, wherein at least a portion of the valve support is configured to apply a radial expansion force up to a predetermined diameter.

21. A prosthetic cardiac valve comprising:

a) a replacement valve comprising;

a plurality of leaflets configured to permit blood to selectively flow therethrough; and

a plurality of commissure points from which the replacement valve is suspended; and

b) a valve support connected to the replacement valve and configured to be collapsible for transluminal delivery,

wherein, when the valve support is implanted in a patient and the replacement valve is positioned in a native aortic valve annulus, said valve support is sized and shaped to extend from a position of the native annulus, past the replacement valve, the commissure points, and the patient'"'"'s coronary ostia, and into an ascending aorta;

wherein outer circumference of the valve support varies along at least some portions of the axial length;

wherein the valve support further comprises;

a first section terminating in a first end, said first end comprising an outer circumference having a first diameter, said first section configured to engage the native annulus; and

a second section terminating in a second end, said second end comprising an outer circumference having a second diameter, said second section configured to extend past the coronary ostia and into the ascending aorta,

wherein the second circumference is greater than the first circumference.