Devices, systems and methods to improve placement and/or prevent heart block with percutaneous aortic valve replacement

Abstract

Devices, systems and methods to position a prosthetic heart valve such that the prosthetic valve is more accurately positioned. Guide devices promote positioning the prosthetic valve within a native aortic valve and, optionally, to center the prosthetic valve within the native heart valve. Prosthetic valves may include one or more cut-outs, openings or recesses configured to align with the conduction tissue so that the conduction tissue is not contacted in a way that would lead to higher incidents of complete heart block.

1 . A prosthetic aortic valve disposable in a native aortic valve of a heart of a patient, the heart having conduction tissue with an upper end disposed below a circumferential portion of the native aortic valve, the prosthetic aortic valve comprising:
 a stent frame having an upper edge, a lower edge, and an interior and expandable from   a collapsed condition to an expanded condition when disposed in the native aortic valve,
 the lower edge defining a substantially planar inflow end of the prosthetic aortic valve and configured to be disposed near the upper end of the conduction tissue when the prosthetic aortic valve is disposed in the native aortic valve, 
 the stent frame having a portion alignable with the circumferential portion of the native aortic valve, the portion of the stent frame being configured to avoid damage to the conduction tissue; and 
   a plurality of prosthetic valve leaflets mounted within the interior of the stent frame to provide unidirectional flow of blood through the prosthetic aortic valve.   
     
     
         2 . The prosthetic aortic valve of  claim 1 , wherein the portion of the stent frame includes an indentation in the stent frame that avoids compressing the conduction tissue when the stent fame is disposed in the expanded condition in the native aortic valve. 
     
     
         3 . The prosthetic aortic valve of  claim 1 , wherein the portion of the stent frame includes a cutout in the stent frame that avoids compressing the conduction tissue when the stent fame is disposed in the expanded condition in the native aortic valve. 
     
     
         4 . The prosthetic aortic valve of  claim 1 , wherein the stent frame is configured to form a complete circumferential seal with the native aortic valve when in the expanded condition. 
     
     
         5 . The prosthetic aortic valve of  claim 4 , wherein the stent frame includes a fabric cover disposed over the stent frame, including over the portion of the stent frame, and configured to form the complete circumferential seal with the native aortic valve. 
     
     
         6 . The prosthetic aortic valve of  claim 5 , wherein the portion of the stent frame is configured to avoid high pressure contact against the conduction tissue. 
     
     
         7 . The prosthetic aortic valve of  claim 1 , further comprising a radiopaque marker disposed on the stent frame to aid in the correct alignment of the portion of the stent frame in relationship to the conduction tissue when the prosthetic aortic valve is disposed in the native aortic valve. 
     
     
         8 . The prosthetic aortic valve of  claim 1 , wherein the stent frame is formed from wire and has a cell pattern, the cell pattern in the portion of the stent frame being different than the cell pattern in the remainder of the stent frame. 
     
     
         9 . The prosthetic aortic valve of  claim 1 , wherein the lower edge of the stent frame is asymmetrical about a plane that bisects the stent frame at a location other than at the portion of the stent frame. 
     
     
         10 . The prosthetic aortic valve of  claim 1 , wherein the lower edge of the stent frame is symmetrical only about a plane that bisects the portion of the stent frame. 
     
     
         11 . The prosthetic aortic valve of  claim 1 , wherein the stent frame is cylindrical. 
     
     
         12 . The prosthetic aortic valve of  claim 1 , wherein the portion of the stent frame is a first portion, the stent frame further including a second portion, circumferentially spaced from the first portion, alignable with the circumferential portion of the native aortic valve, and being configured to avoid damage to the conduction tissue when so aligned. 
     
     
         13 . A prosthetic aortic valve disposable in a native aortic valve of a heart of a patient, the heart having conduction tissue with an upper end disposed below a circumferential portion of the native aortic valve, the prosthetic aortic valve comprising:
 a stent frame having an upper edge, a lower edge, and an interior and expandable from a collapsed condition to an expanded condition when disposed in the native aortic valve,
 the stent frame being formed from wire and having a cell pattern, the cell pattern in a portion of the stent frame being different than the cell pattern in the remainder of the stent frame, 
 the portion of the stent frame being alignable with the circumferential portion of the native aortic valve, the portion of the stent frame being configured to avoid damage to the conduction tissue; and 
   a plurality of prosthetic valve leaflets mounted within the interior of the stent frame to provide unidirectional flow of blood through the prosthetic aortic valve.   
     
     
         14 . The prosthetic aortic valve of  claim 13 , wherein the portion of the stent frame includes an indentation in the stent frame that avoids compressing the conduction tissue when the stent fame is disposed in the expanded condition in the native aortic valve. 
     
     
         15 . The prosthetic aortic valve of  claim 13 , wherein the stent frame is configured to form a complete circumferential seal with the native aortic valve when in the expanded condition. 
     
     
         16 . The prosthetic aortic valve of  claim 15 , wherein the stent frame includes a fabric cover disposed over the stent frame, including over the portion of the stent frame, and configured to form the complete circumferential seal with the native aortic valve. 
     
     
         17 . The prosthetic aortic valve of  claim 16 , wherein the portion of the stent frame is configured to avoid high pressure contact against the conduction tissue. 
     
     
         18 . The prosthetic aortic valve of  claim 13 , further comprising a radiopaque marker disposed on the stent frame to aid in the correct alignment of the portion of the stent frame in relationship to the conduction tissue when the prosthetic aortic valve is disposed in the native aortic valve. 
     
     
         19 . The prosthetic aortic valve of  claim 13 , wherein the lower edge defines a substantially planar inflow end of the prosthetic aortic valve and is configured to be disposed near the upper end of the conduction tissue when the prosthetic aortic valve is disposed in the native aortic valve. 
     
     
         20 . The prosthetic aortic valve of  claim 13 , wherein the lower edge of the stent frame is asymmetrical about a plane that bisects the stent frame at a location other than at the portion of the stent frame. 
     
     
         21 . The prosthetic aortic valve of  claim 13 , wherein the lower edge of the stent frame is symmetrical only about a plane that bisects the portion of the stent frame. 
     
     
         22 . The prosthetic aortic valve of  claim 13 , wherein the stent frame is cylindrical. 
     
     
         23 . The prosthetic aortic valve of  claim 13 , wherein the portion of the stent frame is a first portion, the stent frame further including a second portion, circumferentially spaced from the first portion, alignable with the circumferential portion of the native aortic valve, and being configured to avoid damage to the conduction tissue when so aligned.