Apparatus and methods for filtering emboli during precutaneous aortic valve replacement and repair procedures with filtration system coupled to distal end of sheath

Abstract

Embodiments of the present invention provide apparatus and methods for embolic filtering during percutaneous valve replacement and repair procedures. Under one aspect, an apparatus comprises a sheath and a filter. The sheath has proximal and distal ends and a lumen therebetween. The distal end may be introduced into the aortic arch via the peripheral arteries and ascending aorta, while the proximal end may be disposed outside of the body. The lumen permits percutaneous aortic valve replacement or repair therethrough. The filter has a frame with an inlet and an outlet and an emboli-filtering mesh attached to the frame. The inlet is substantially spans the aortic arch in a region between the aortic valve and the great arteries. The outlet is coupled to the distal end of the sheath without leaving any gaps through which emboli could pass and without obstructing the lumen at the distal end of the sheath.

What is claimed: 
     
         1 . Apparatus for filtering emboli during a percutaneous aortic valve replacement or repair procedure, the apparatus comprising:
 a sheath having proximal and distal ends and a lumen therebetween, the distal end being configured for introduction into the aortic arch via the peripheral arteries and ascending aorta, the proximal end being configured to be disposed outside of the body, the lumen being sized to permit percutaneous aortic valve replacement or repair therethrough; and   a filter having a frame and an emboli-filtering mesh attached to the frame, the frame having an inlet and an outlet, the inlet being configured to substantially span the aortic arch in a region between the aortic valve and the great arteries, the outlet being coupled to the distal end of the sheath without leaving any gaps through which emboli could pass and without obstructing the lumen at the distal end of the sheath.   
     
     
         2 . The apparatus of  claim 1 , further comprising a release line coupled to the frame of the filter and passing out of the body through the lumen, the release line being retractable from outside of the body to detach the outlet of the filter from the distal end of the sheath. 
     
     
         3 . The apparatus of  claim 2 , wherein a groove is defined in the lumen of the sheath and configured to receive the release line. 
     
     
         4 . The apparatus of  claim 2 , further comprising a snare coupled to the frame of the filter and passing out of the body through the lumen, the snare being retractable from outside of the body to draw the filter into the lumen. 
     
     
         5 . The apparatus of  claim 4 , wherein a groove is defined in the lumen of the sheath and configured to receive the snare. 
     
     
         6 . The apparatus of  claim 1 , further comprising a snare coupled to the frame of the filter and passing out of the body through the lumen, the snare being retractable from outside of the body to detach the outlet of the filter from the distal end of the sheath and to draw the filter into the lumen. 
     
     
         7 . The apparatus of  claim 1 , wherein the frame comprises a generally cylindrical ring defining the inlet. 
     
     
         8 . The apparatus of  claim 7 , wherein the frame further comprises a generally cylindrical ring defining the outlet. 
     
     
         9 . The apparatus of  claim 8 , wherein the frame further comprises a plurality of struts between the rings defining the inlet and the outlet. 
     
     
         10 . The apparatus of  claim 1 , wherein the sheath has an inner diameter of 18 French or less. 
     
     
         11 . The apparatus of  claim 10 , wherein the outlet of the filter has an outer diameter that is greater than the inner diameter of the sheath. 
     
     
         12 . The apparatus of  claim 10 , wherein the outlet of the filter has an inner diameter that is greater than the inner diameter of the sheath. 
     
     
         13 . The apparatus of  claim 1 , the filter having a compressed state and a deployed state, the apparatus further comprising a guidewire and an introducer for use in percutaneously introducing the filter and the distal end of the sheath into the aortic arch, the introducer comprising:
 a tapered distal nose;   a proximal end;   a guidewire lumen configured to receive the guidewire; and   a recess between the distal nose and the proximal end, the recess being configured to receive the filter in the compressed state,   the introducer being configured for insertion within the lumen at the distal end of the sheath and to retain the filter in the compressed state within the recess,   the introducer, the filter, and the distal end of the sheath being percutaneously introducible into the aortic arch by pushing the introducer over the guidewire via the sheath.   
     
     
         14 . The apparatus of  claim 13 , further comprising a control wire coupled to the introducer, the control wire configured to advance the introducer while the sheath is held in place, such advancement of the introducer allowing the filter to expand from the compressed state to the deployed state. 
     
     
         15 . The apparatus of  claim 14 , the introducer being retrievable through the outlet of the filter and the lumen of the sheath after the filter expands to the deployed state by retracting the control wire. 
     
     
         16 . The apparatus of  claim 13 , wherein a portion of the sheath is pre-curved to conform to the aortic arch, wherein the introducer straightens the pre-curved portion of the sheath when inserted therein. 
     
     
         17 . A method of filtering emboli during a percutaneous aortic valve replacement or repair procedure, the method comprising:
 providing a sheath having proximal and distal ends and a lumen therebetween;   providing a filter having a compressed state and a deployed state, the filter having a frame and an emboli-filtering mesh attached to the frame, the frame having an inlet and an outlet, the inlet being configured to substantially span the aortic arch in a region between the aortic valve and the great arteries in the deployed state, the outlet being coupled to the distal end of the sheath without leaving any gaps through which emboli could pass and without obstructing the lumen at the distal end of the sheath;   percutaneously introducing the distal end of the sheath into the aortic arch; and   expanding the filter from the compressed state to the deployed state within the aortic arch.   
     
     
         18 . The method of  claim 17 , further comprising detaching the outlet of the filter from the distal end of the sheath by retracting a release line coupled to the frame of the filter and passing out of the body through the lumen. 
     
     
         19 . The method of  claim 18 , further comprising retracting the filter into the lumen with a snare coupled to the frame of the filter and passing out of the body through the lumen. 
     
     
         20 . The method of  claim 17 , further comprising:
 providing a guidewire and an introducer having a guidewire lumen configured to receive the guidewire, the introducer having a recess configured to receive the filter in the compressed state;   compressing the filter to the compressed state within the recess of the introducer;   inserting the introducer into the lumen at the distal end of the sheath and retaining the filter in the compressed state within the recess and between the introducer and the sheath; and   percutaneously introducing the introducer, the filter, and the sheath into the aortic arch by pushing the introducer over the guidewire via the sheath.   
     
     
         21 . The method of  claim 20 , wherein said expanding comprises advancing the introducer while maintaining the sheath in place so as to expose the filter and allow the filter to expand from the compressed state to the deployed state. 
     
     
         22 . The method of  claim 21 , further comprising retrieving the introducer through the outlet of the filter and the lumen of the sheath after the filter expands to the deployed state.