ECM strip to plug percutaneous heart valve leaks
View Patent ↗Described are devices and methods for medically sealing a perivalvular leak associated with implanted valves. For example, a bioresorbable tissue infiltratable sheet is provided for insertion through a perivalvular leak. A filament extending through the sheet is also provided which when pulled causes the sheet to gather around the filament on either side of the perivalvular leak. The gathered position of the sheet may be secured by a series of stops and/or use of a capping member.
1. A method for obstructing a perivalvular leak, the method comprising:
delivering a closure device to a perivalvular leak, the leak defining a space between a valve and patient tissue, said closure device comprising an elongate strip of bioresorbable tissue infiltratable material sized and configured to transverse a perivalvular leak, said closure device also containing one or more filaments slidably associated with said material at a plurality of locations;
inserting the closure device through the perivalvular leak, such that a first portion of said closure device protrudes on a distal side of the perivalvular leak, a second portion of said closure device extends through the perivalvular leak between the external surface of the valve and patient tissue, a third portion of said closure device protrudes on a proximal side of the perivalvular leak; and
deforming said elongate strip such that said first portion gathers substantially over the distal side of the perivalvular leak, and said third portion gathers substantially over the proximal side of the perivalvular leak.
2. The method of claim 1 wherein:
said bioresorbable tissue infiltratable sheet material comprises extracellular matrix material.
3. The method of claim 1 further comprising:
attaching said closure device to the vessel wall.
4. The method of claim 1 further comprising:
securing the position of said closure device on said filament.
5. The method of claim 1 further comprising:
introducing a capping element over said filament, wherein said capping element contains a filament channel which receives said filament.
6. A method for obstructing a perivalvular leak between patient tissue and an implanted heart valve, the method comprising:
inserting a cannulated device through the perivalvular leak from a proximal side to a distal side;
deploying a first portion of a closure device from the cannulated device on the distal side of the perivalvular leak, said closure device comprising a strip of bioresorbable tissue infiltratable material sized and configured to transverse a perivalvular leak, said closure device also containing one or more filaments slidably extending through a plurality of openings;
deforming said first portion to an expanded cross-sectional profile;
retracting said cannulated device through the perivalvular leak;
deploying of a second portion of said closure device extending through the perivalvular leak and protruding on the proximal side of the perivalvular leak; and
deforming said second portion to an expanded cross-sectional profile.
7. The method of claim 6 wherein:
said bioresorbable tissue infiltratable sheet material comprises extracellular matrix material.
8. The method of claim 6 further comprising:
attaching said closure device to the vessel wall on the distal side of the perivalvular leak.
9. The method of claim 6 further comprising:
attaching said closure device to the vessel wall on the proximal side of the perivalvular leak.
10. The method of claim 6 further comprising:
securing the position of the closure device on the filament such that the closure device maintains the expanded cross-sectional profile.
11. The method of claim 6 further comprising:
introducing a capping element over said filament, wherein said capping element contains a filament channel which receives said filament.
12. A method for obstructing a perivalvular leak associated with an implanted artificial valve, the method comprising:
inserting a closure device into a perivalvular leak, the perivalvular leak comprising a gap between patient tissue and an implanted artificial valve, the artificial valve having an outer surface, wherein the perivalvular leak comprises a passage between a first opening defined by the outer surface of the artificial valve and patient tissue and a second opening defined by the outer surface of the artificial valve and patient tissue, and wherein the closure device comprises a bioresorbable tissue infiltratable material sheet, and wherein said inserting causes a first portion of the closure device to extend from the first opening of the perivalvular leak and a second portion of the closure device to extend from the second opening of the perivalvular leak with an intermediate portion extending between the first and second openings transversing the perivalvular leak passage; and
deforming the closure device so as to cause the bioresorbable tissue infiltratable material sheet to push against the outer surface of the artificial valve and patient tissue so as to occlude the perivalvular leak.
13. The method of claim 12 , wherein:
said deforming causes the first portion of the closure device to form a first gathered region over the first opening of the perivalvular leak.
14. The method of claim 13 , wherein:
said deforming also causes the second portion of the closure device to form a second gathered region over the second opening of the perivalvular leak.
15. The method of claim 12 , wherein:
said deforming is caused by tensioning a filament, the filament attached to and slidably associated with the bioresorbable tissue infiltratable material sheet.
16. The method of claim 12 wherein:
said bioresorbable tissue infiltratable sheet material comprises extracellular matrix material.