Systems and methods for transcatheter aortic valve treatment

Abstract

Devices and methods are configured to allow transcervical or subclavian access via the common carotid artery to the native aortic valve, and implantation of a prosthetic aortic valve into the heart. The devices and methods also provide means for embolic protection during such an endovascular aortic valve implantation procedure.

What is claimed is: 
     
         1 . A system for aortic valve treatment of a heart, the system comprising:
 an arterial access sheath comprising a proximal end region, a distal end region, and an internal lumen extending between the proximal end region and distal end region, the proximal end region coupled to a hemostatic device and the distal end region coupled to an embolic protection filter,   wherein the internal lumen of the arterial access sheath is sized and shaped to receive a valve delivery system configured to deliver a prosthetic valve into the heart through the arterial access sheath, and   wherein the embolic protection filter is reconfigurable between a first configuration in which the embolic protection filter is in a collapsed state configured for insertion to a vessel and a second configuration in which the embolic protection filter is in a deployed state configured to deploy across a diameter of the vessel,   wherein the embolic protection filter in the deployed state captures embolic material flowing through the vessel.   
     
     
         2 . A system as in  claim 1 , wherein the arterial access sheath has a working length adapted to be introduced into an access site at the left common carotid artery, right common carotid artery, left subclavian artery, or right subclavian artery. 
     
     
         3 . A system as in  claim 1 , wherein the embolic protection filter comprises an expandable frame and a filter material covering the frame. 
     
     
         4 . A system as in  claim 3 , wherein the filter material is a woven textile material or a knitted textile material. 
     
     
         5 . A system as in  claim 3 , wherein the filter material is a perforated polymer membrane. 
     
     
         6 . A system as in  claim 3 , wherein the filter material has a porosity that is between 40 micron porosity and 300 micron porosity. 
     
     
         7 . A system as in  claim 3 , wherein the expandable frame is formed of a spring material. 
     
     
         8 . A system as in  claim 7 , wherein the spring material is stainless steel, Nitinol wire, or Nitinol ribbon. 
     
     
         9 . A system as in  claim 3 , wherein the expandable frame is a loop having an expanded diameter between 12 mm and 30 mm. 
     
     
         10 . A system as in  claim 3 , wherein the expandable frame is formed by a series of struts connected at one or both ends of the embolic protection filter. 
     
     
         11 . A system as in  claim 1 , wherein the embolic protection filter has a cone shape or a closed-end tube shape. 
     
     
         12 . A system as in  claim 1 , wherein the embolic protection filter in the deployed state has a long dimension of between 2 cm and 5 cm and a short dimension of between 1 cm and 2 cm. 
     
     
         13 . A system as in  claim 1 , further comprising a valve delivery system configured to deliver a prosthetic valve into the heart through the arterial access sheath. 
     
     
         14 . A system as in  claim 1 , further comprising an occlusion element on the arterial access sheath, the occlusion element adapted to occlude an artery. 
     
     
         15 . A system as in  claim 14 , wherein the occlusion element is a balloon. 
     
     
         16 . A system as in  claim 1 , wherein the sheath has an aspiration port. 
     
     
         17 . A system as in  claim 16 , further comprising an aspiration source coupled to the aspiration port. 
     
     
         18 . A system as in  claim 1 , further comprising a collection reservoir fluidly coupled to the access sheath and adapted to receive fluid from the sheath. 
     
     
         19 . A system as in  claim 1 , further comprising a venous return shunt fluidly coupled to the access sheath and adapted to receive fluid from the sheath for passing to a vein. 
     
     
         20 . A system as in  claim 1 , wherein the vessel is the ascending aorta or a region of the aortic arch.