STENTLESS AORTIC VALVE REPLACEMENT WITH HIGH RADIAL STRENGTH

• US 20070005133A1
• Filed: 06/07/2006
• Published: 01/04/2007
• Est. Priority Date: 06/07/2005
• Status: Active Grant

• Current Assignee: Speyside Medical, LLC
• Original Assignee: Direct Flow Medical, Inc.
• Inventors: Lashinski, Randall, Bishop, Gordon
• Granted Patent: US 8,568,477 B2
• Time in Patent Office: Days
• US Class Current: 623/2.170
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• 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 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

Disclosed is a stentless transluminally implantable heart valve, having a formed in place support. The formed in place support exhibits superior crush resistance when compared to conventional balloon expandable or self expandable stent based valves.

Claims

1. A cardiovascular prosthetic valve, the valve comprising:

an inflatable cuff comprising at least one inflatable channel that forms, at least in part, a distal inflatable toroidal structure and a proximal inflatable toroidal structure, the inflatable cuff also comprising a waist that extends between the distal inflatable toroidal structure and the proximal inflatable toroidal structure; and

a valve coupled to the inflatable cuff, the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction;

wherein the inflatable cuff exhibits sufficient crush resistance that it will deform radially no more than about 0.3 inches under a load of about 4 pounds.

2. The valve of claim 1, wherein the at least one inflatable channel includes a first chamber associated with the distal inflatable toroidal structure and a second, independent, chamber associated with the proximal inflatable toroidal structure.

8. The method of claim 1, wherein inflating a first chamber of the inflatable structure comprising inflating a distal end of the valve.

9. The method of claim 2, further comprising proximally retracting the valve after the first chamber is at least partially inflated.

10. The method of claim 1, wherein inflating a second chamber of the inflatable structure comprising inflating a proximal end of the valve.

3. A prosthetic valve for replacing an aortic valve positioned between the left ventricle and the aorta of the heart, the valve comprising:

an inflatable structure comprising a distal end and a proximal end; and

a valve member coupled to the inflatable structure, the valve member being positioned generally between the distal and proximal ends of the inflatable structure;

wherein the distal end of the inflatable structure is configured to be positioned within the left ventricle and the proximal end of the inflatable structure is configured to be positioned within the aorta; and

wherein the inflatable structure exhibits sufficient crush resistance that it will deform radially no more than about 0.3 inches under a load of about 4 pounds.

4. The valve of claim 3, wherein the inflatable structure includes a first chamber associated with the distal end and a second separate chamber associated with the proximal end.

5. A cardiovascular prosthetic valve, the valve comprising:

an inflatable body comprising at least a first inflatable chamber and a second inflatable chamber that is not in fluid communication with the first inflatable chamber, the inflatable body configured to form, at least in part, a generally annular ring;

a valve coupled to the inflatable body, the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction;

a first inflation port in communication with the first inflatable chamber; and

a second inflation port in communication with the second inflatable chamber;

wherein the inflatable cuff exhibits sufficient crush resistance that it will deform radially no more than about 0.3 inches under a load of about 4 pounds.

6. A cardiovascular prosthetic valve, the valve comprising:

an inflatable body;

a valve coupled to the body;

the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction; and

at least two control wires that are detachably coupled to the inflatable body;

wherein the inflatable cuff exhibits sufficient crush resistance that it will deform radially no more than about 0.3 inches under a load of about 4 pounds.

7. A method of implanting a prosthetic valve within the heart, the method comprising:

translumenally advancing a prosthetic valve comprising an inflatable structure to a position proximate a native valve of the heart;

inflating a first chamber of the inflatable structure; and

independently inflating a second chamber of the inflatable structure;

wherein the inflatable cuff exhibits sufficient crush resistance that it will deform radially no more than about 0.3 inches under a load of about 4 pounds.

11. A method of treating a patient, comprising the steps of:

identifying a patient with a minimum cross-minimum flow area through an aortic valve of no greater than 0.75 square cm;

enlarging the minimum cross-minimum flow area through the valve; and

deploying a prosthetic valve which provides a minimum cross-sectional flow area of ate least about 1.75 square cm;

wherein the prosthetic valve exhibits sufficient crush resistance that it will deform radially no more than about 0.3 inches under a load of about 4 pounds.

12. A method of treating a patient, comprising the steps of:

inflating an inflatable structure of a temporary valve at a cardiovascular site in fluid communication with a native valve;

translumenally removing at least a portion of the native valve;

deploying a prosthetic valve to compliment or replace a native valve; and

removing the temporary valve;

wherein the prosthetic valve exhibits sufficient crush resistance that it will deform radially no more than about 0.3 inches under a load of about 4 pounds.

13. A method of performing a procedure on a beating heart, comprising the steps of:

positioning a temporary valve in series fluid flow with a native valve;

deploying an inflatable prosthetic valve upstream of the temporary valve; and

removing the temporary valve;

wherein the prosthetic valve exhibits sufficient crush resistance that it will deform radially no more than about 0.3 inches under a load of about 4 pounds.