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 method of treating an aortic valve of a heart, the method comprising:
 forming a penetration at the neck of a patient in a wall of a common carotid artery;   introducing an arterial access sheath through the penetration, the arterial access sheath comprising a proximal end region, a distal end region, and an internal lumen extending between the proximal end region and the distal end region, the proximal end region coupled to a hemostatic device and the distal end region coupled to an embolic protection filter in a collapsed state configured for insertion to a vessel;   deploying the embolic protection filter from the collapsed state to a deployed state configured to deploy across a diameter of the vessel to capture embolic material flowing through the vessel to provide embolic protection;   inserting a guide wire across a native aortic valve; and   introducing a prosthetic valve through the arterial access sheath and deploying the prosthetic valve at or near the position of the native aortic valve.   
     
     
         2 . A method as in  claim 1 , further comprising:
 collapsing the embolic protection filter;   removing the arterial access sheath; and   closing the penetration.   
     
     
         3 . A method as in  claim 2 , wherein the embolic protection filter is withdrawn or removed prior to removing the arterial access sheath. 
     
     
         4 . A method as in  claim 1 , further comprising applying a closure device at a site of the penetration before introducing the arterial access sheath through the penetration. 
     
     
         5 . A method as in  claim 4 , wherein the closure device comprises a suture-based closure device. 
     
     
         6 . A method as in  claim 1 , wherein the vessel is the ascending aorta or a region of the aortic arch. 
     
     
         7 . A method as in  claim 1 , further comprising occluding the common carotid artery. 
     
     
         8 . A method as in  claim 7 , further comprising establishing blood flow from the common carotid artery such that blood flows into the internal lumen of the arterial access sheath. 
     
     
         9 . A method as in  claim 8 , further the blood flows out a side opening located between the distal end and the proximal end of the arterial access sheath. 
     
     
         10 . A method as in  claim 8 , wherein the blood flows into a shunt connected to the access sheath. 
     
     
         11 . A method as in  claim 10 , further comprising fluidly connecting the shunt to a collection reservoir or a venous return site in the patient. 
     
     
         12 . A method as in  claim 8 , further comprising regulating the rate of flow from the common carotid artery. 
     
     
         13 . A method as in  claim 7 , further comprising applying aspiration to the artery through the access sheath. 
     
     
         14 . A method as in  claim 13 , further comprising regulating a rate of the aspiration. 
     
     
         15 . A method as in  claim 7 , wherein occluding the common carotid artery comprises inflating an occlusion balloon on the arterial access sheath. 
     
     
         16 . A method as in  claim 1 , wherein the internal lumen of the arterial access sheath is sized and shaped to receive a valve delivery system configured to deliver the prosthetic valve into the heart through the arterial access sheath. 
     
     
         17 . A method as in  claim 1 , wherein the embolic protection filter comprises an expandable frame and a filter material covering the frame. 
     
     
         18 . A method as in  claim 17 , wherein the filter material is a woven textile material or a knitted textile material. 
     
     
         19 . A method as in  claim 17 , wherein the filter material is a perforated polymer membrane. 
     
     
         20 . A method as in  claim 17 , wherein the filter material has a porosity that is between 40 micron porosity and 300 micron porosity. 
     
     
         21 . A method as in  claim 17 , wherein the expandable frame is formed of a spring material. 
     
     
         22 . A method as in  claim 21 , wherein the spring material is stainless steel, Nitinol wire, or Nitinol ribbon. 
     
     
         23 . A method as in  claim 17 , wherein the expandable frame is a loop having an expanded diameter between 12 mm and 30 mm. 
     
     
         24 . A method as in  claim 17 , wherein the expandable frame is formed by a series of struts connected at one or both ends of the embolic protection filter. 
     
     
         25 . A method as in  claim 1 , wherein the embolic protection filter has a cone shape or a closed-end tube shape.