Apparatus And Methods For Trans-Septal Retrieval Of Prosthetic Heart Valves

Abstract

In some embodiments, a method for transfemoral retrieval and/or repositioning of a prosthetic valve implanted within a heart includes inserting a retrieval assembly through a femoral vein and into a heart until a distal end portion of the retrieval assembly is disposed in an atrium of the heart. The prosthetic valve is formed with a shape-memory material. The retrieval assembly includes an outer catheter, a middle catheter, a snare catheter, and a snare member. The snare member is moved distally out of a lumen of the snare catheter and into engagement with an inner frame of the prosthetic valve. The retrieval assembly can invert an outer frame of the prosthetic valve to collapse and retract the valve into a lumen of the retrieval assembly. In some embodiments, a positioning catheter can be inserted through the apex of the heart to assist in positioning and inverting the prosthetic valve.

What is claimed is: 
     
         1 . An apparatus, comprising:
 a retrieval assembly including an outer catheter, a middle catheter and a snare catheter, and a snare member movably disposable within a lumen of the snare catheter,   the snare catheter movably disposable within a lumen of the middle catheter,   the middle catheter movably disposable within a lumen of the outer catheter,   the snare member including an engagement portion that can be moved between a collapsed configuration when disposed within the lumen of the snare catheter and an expanded configuration when moved outside the lumen of the snare catheter, the engagement portion configured to engage and surround at least a portion of an inner frame of a prosthetic heart valve implanted within a heart such that the prosthetic heart valve can be repositioned or removed from the heart with the apparatus.   
     
     
         2 . The apparatus of  claim 1 , wherein the engagement portion is formed with a shape-memory material such that the engagement portion automatically moves to the expanded configuration when moved outside of the lumen of the snare catheter. 
     
     
         3 . The apparatus of  claim 1 , wherein the outer catheter has a rigid distal tip. 
     
     
         4 . The apparatus of  claim 1 , wherein the engagement portion of the snare member includes at least one loop configured to surround at least a portion of the prosthetic heart valve. 
     
     
         5 . The apparatus of  claim 1 , wherein the engagement portion of the snare member has a coil shape and is configured to surround at least a portion of the prosthetic heart valve. 
     
     
         6 . The apparatus of  claim 5 , wherein the coil shape includes multiple loops having the same diameter when expanded. 
     
     
         7 . The apparatus of  claim 5 , wherein the coil shape includes multiple loops having different diameters when expanded. 
     
     
         8 . The apparatus of  claim 1 , further comprising:
 a positioning catheter having a distal end, the distal end configured to engage a portion of the prosthetic heart valve such that the positioning catheter can move the prosthetic heart valve toward the outer catheter of the retrieval assembly.   
     
     
         9 . The apparatus of  claim 8 , wherein the positioning catheter defines a lumen, a tether coupled to the prosthetic heart valve can be movably disposed within the lumen of the positioning catheter. 
     
     
         10 . The apparatus of  claim 8 , wherein the distal end of the positioning catheter is configured to be inserted into and movably disposed within the outer catheter. 
     
     
         11 . A system, comprising:
 a prosthetic heart valve having an outer frame, and inner frame disposed within the outer frame, and a valve assembly coupled to the inner frame, the outer frame being invertible relative to the inner frame; and   a retrieval assembly including an outer catheter, a middle catheter and a snare catheter, and a snare member movably disposable within a lumen of the snare catheter,   the snare catheter movably disposable within a lumen of the middle catheter,   the middle catheter movably disposable within a lumen of the outer catheter,   the snare member including an engagement portion that can be moved between a collapsed configuration when disposed within the lumen of the snare catheter and an expanded configuration when moved outside the lumen of the snare catheter, the engagement portion configured to engage and surround at least a portion of the inner frame of the prosthetic heart valve implanted within a heart such that the prosthetic heart valve can be repositioned or removed from the heart with the retrieval assembly.   
     
     
         12 . The system of  claim 11 , wherein the engagement portion is formed with a shape-memory material such that the engagement portion automatically moves to the expanded configuration when moved outside of the lumen of the snare catheter. 
     
     
         13 . The system of  claim 11 , wherein the outer catheter has a rigid distal tip. 
     
     
         14 . The system of  claim 11 , wherein the engagement portion of the snare member includes at least one loop configured to surround at least a portion of the prosthetic heart valve. 
     
     
         15 . The system of  claim 11 , wherein the engagement portion of the snare member has a coil shape and is configured to surround at least a portion of the prosthetic heart valve. 
     
     
         16 . The system of  claim 15 , wherein the coil shape includes multiple loops having the same diameter when expanded. 
     
     
         17 . The system of  claim 15 , wherein the coil shape includes multiple loops having different diameters when expanded. 
     
     
         18 . The system of  claim 11 , further comprising:
 a positioning catheter having a distal end, the distal end configured to engage a portion of the prosthetic heart valve such that the positioning catheter can move the prosthetic heart valve toward the outer catheter of the retrieval assembly.   
     
     
         19 . The system of  claim 18 , wherein the positioning catheter defines a lumen, a tether coupled to the prosthetic heart valve can be movably disposed within the lumen of the positioning catheter. 
     
     
         20 . The system of  claim 18 , wherein the distal end of the positioning catheter is configured to be inserted into and movably disposed within the outer catheter.