Paravalvular leak detection, sealing, and prevention

• US 7,276,078 B2
• Filed: 06/30/2004
• Issued: 10/02/2007
• Est. Priority Date: 06/30/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation, Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Inventors: Benichou, Netanel, Spenser, Benjamin, Bash, Assaf
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/883,575
• Publication Number:
  US 20060004442A1
• Time in Patent Office: 1,189 Days
• Field of Search: 623 21- 241
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

The present invention provides a series of new percutaneous concepts of paravalvular repairs including identifying the leak location, several repair techniques and finally built-in means for leak prevention, built on percutaneous valves. A catheter-delivered device locates cavities occurring between a prosthetic valve and the wall of the body vessel where the valve is implanted, the cavities producing paravalvular leaks during diastole, the device comprising at least one of a plurality of flexible wires, the wire having attached to it a balloon, wherein the balloon is pulled by the leak through the cavity and wherein the wire then serves to mark the cavity location.

Claims

1. A prosthetic valve with integrated sealing ring attached to the outside wall, the ring having a circumference greater than that of the valve and elastically conforming to seal cavities between the valve and the wall of the body vessel where the valve is implanted, the cavities producing paravalvular leaks during diastole wherein the ring comprises a plurality of spring-wire tabs mounted adjacent to one another around the circumference of the valve and covered with an impermeable membrane and wherein the tabs are folded against the body of the valve during catheter delivery and where, upon egress from the catheter, the tabs spring out to form the sealing ring.

2. A prosthetic valve with integrated sealing ring attached to the outside wall, the ring having a circumference greater than that of the valve and elastically conforming to seal cavities between the valve and the wall of the body vessel where the valve is implanted, the cavities producing paravalvular leaks during diastole wherein the ring comprises a plurality of impermeable tabs mounted adjacent to one another around the circumference of the valve, and further comprising a balloon under the tabs and wherein the tabs are folded down on the deflated balloon during catheter delivery and wherein, upon egress from the catheter, the balloon is inflated, hereby opening the tabs to form the sealing ring.

3. A prosthetic valve with integrated sealing ring attached to the outside wall, the ring having a circumference greater than that of the valve and elastically conforming to seal cavities between the valve and the wall of the body vessel where the valve is implanted, the cavities producing paravalvular leaks during diastole wherein the ring comprises a plurality of impermeable tabs mounted adjacent to one another around the circumference of the valve, each tab spring hinged to the valve and wherein the tabs are folded against the body of the valve during catheter delivery and wherein, upon egress from the catheter, the tabs spring out to form the sealing ring.

4. A prosthetic valve with integrated sealing ring attached to the outside wall, the ring having circumference greater than that of the valve and elastically conforming to seal cavities between the valve and the wall of the body vessel where the valve is implanted, the cavities producing paravalvular leaks during diastole wherein the ring comprises at least one of a plurality of flexible, self-expanding sealing elements comprised of self expanding mesh covered with an impermeable membrane.

5. A prosthetic valve with integrated sealing means, the sealing means comprising sutures attached around the perimeter of the valve and extending back out of the body and wherein patches can be pushed down the sutures and attached to the point where the suture is attached to the valve, thereby sealing any cavity existing between the valve and the wall of the body vessel where the valve is implanted, the cavities producing paravalvular leaks during diastole.

6. A catheter-delivered prosthetic valve with integrated sealing means, the sealing means comprising an elastic stent that is first deployed and inside which the valve is deployed, the elastic stent sealing any cavity existing between the valve and the wall of the body vessel where the valve is implanted, the cavities producing paravalvular leaks during diastole.