Devices and methods for treating aortic valve stenosis

Abstract

Devices and methods for their use in increasing the aortic valve flow of a stenotic aortic valve are provided. The subject devices include an aortic valve isolation element and an aortic valve flushing element. The aortic valve isolation element is made up of a ventricular side aortic valve occlusion element, coronary ostia occlusion elements and an ascending aorta occlusion element. The aortic valve flushing element is made up of a dissolution fluid introducing element and a fluid removal element. In practicing the subject methods, a stenotic aortic valve is first isolated. Next, the isolated valve is flushed with a dissolution fluid, e.g., an acidic dissolution fluid, for a period of time sufficient for the aortic valve flow of the treated valve to be increased. In certain embodiments, the valve is also contacted with a dissolution fluid attenuating fluid, e.g., a buffer, during the flushing step in order to limit the contact of non-valve tissue with the dissolution fluid. Also provided are systems and kits that include the subject devices and can be employed in practicing the subject methods. The subject devices, methods, systems and kits find use in treating conditions associated with the presence of stenotic aortic valves.

What is claimed is:  
     
         1 . A device for use in increasing the aortic valve area of a stenotic aortic valve, said device comprising: 
 (a) a valve isolation element that includes: 
 (i) a ventricular side aortic valve occlusion element;  
 (ii) coronary ostia occlusion element; and  
 (iii) an ascending aorta occlusion element; and  
   (b) an aortic valve flushing element for flushing an isolated aortic valve with a dissolution fluid.    
     
     
         2 . The device according to  claim 1 , wherein said flushing element includes: 
 (a) a first fluid introducing element; and    (b) a fluid aspiration element.    
     
     
         3 . The device according to  claim 2 , wherein said flushing element further comprises a second fluid introducing element.  
     
     
         4 . The device according to  claim 3 , wherein said first and second fluid introducing elements are at least substantially coterminus.  
     
     
         5 . The device according to  claim 3 , wherein said first and second fluid introducing elements are not coterminus.  
     
     
         6 . The device according to  claim 2 , wherein said first fluid introducing element is in fluid communication with a source of stenotic dissolution fluid.  
     
     
         7 . The device according to  claim 6 , wherein said stenotic dissolution fluid is an acidic dissolution fluid.  
     
     
         8 . The device according to  claim 3 , wherein said first fluid introducing element is in fluid communication with a source of stenotic dissolution fluid and said second fluid introducing element is in fluid communication with a source of stenotic dissolution fluid attenuating fluid.  
     
     
         9 . The device according to  claim 8 , wherein said stenotic dissolution fluid is an acidic dissolution fluid and said stenotic dissolution fluid attenuating fluid is a pH elevating fluid.  
     
     
         10 . The device according to  claim 9 , wherein said pH elevating fluid is a buffer.  
     
     
         11 . The device according to  claim 1 , wherein said device further includes an element that provides for blood flow through an aortic valve isolated with said valve isolation element.  
     
     
         12 . The device according to  claim 1 , wherein said ventricular side aortic valve occlusion element is a balloon.  
     
     
         13 . The device according to  claim 1 , wherein said coronary ostia occlusion elements are balloons.  
     
     
         14 . The device according to  claim 1 , wherein said ascending aorta occlusion element is a balloon.  
     
     
         15 . A method of increasing the aortic valve area of a stenotic aortic valve, said method comprising: 
 (a) isolating said stenotic aortic valve with a valve isolation element that includes: 
 (i) a ventricular side aortic valve occlusion element;  
 (ii) coronary ostia occlusion elements; and  
 (iii) an ascending aorta occlusion element; and  
   (b) flushing said isolated stenotic aortic valve with a stenosis dissolution fluid for a period of time sufficient to increase said stenotic aortic valve's aortic valve area.    
     
     
         16 . The method according to  claim 15 , wherein said isolating step comprises activating said ventricular side aortic valve occlusion element followed by activating said coronary ostia and ascending aorta occlusion elements.  
     
     
         17 . The method according to  claim 15 , wherein said flushing comprises contacting said isolated stenotic aortic valve with said stenosis dissolution fluid and removing fluid from said isolated stenotic aortic valve.  
     
     
         18 . The method according to  claim 17 , wherein said dissolution fluid is an acidic dissolution fluid.  
     
     
         19 . The method according to  claim 17 , wherein said method further comprises contacting said isolated stenotic aortic valve with a dissolution fluid attenuating fluid.  
     
     
         20 . The method according to  claim 19 , wherein said dissolution fluid is an acidic dissolution fluid and said dissolution fluid attenuating fluid is a pH elevating fluid.  
     
     
         21 . The method according to  claim 20 , wherein said pH elevating fluid is a buffer.  
     
     
         22 . The method according to  claim 19 , wherein said stenotic dissolution fluid is contacted with the aortic side of said stenotic aortic valve and said dissolution fluid attenuating fluid is contacted with the ventricular side of said stenotic aortic valve.  
     
     
         23 . The method according to  claim 15 , wherein said stenotic aortic valve is present in a heart of a mammalian host.  
     
     
         24 . The method according to  claim 23 , wherein said mammalian host is a human.  
     
     
         25 . The method according to  claim 24 , wherein said method further comprises arresting said heart prior to said isolating step.  
     
     
         26 . A method of at least reducing the amount of calcium mineral present on a calcified aortic valve, said method comprising: 
 (a) isolating said calcified aortic valve with a valve isolation element that includes: 
 (i) a ventricular side aortic valve occlusion element;  
 (ii) coronary ostia occlusion elements; and  
 (iii) an ascending aorta occlusion element; and  
   (b) flushing said isolated calcified aortic valve with an acidic dissolution fluid for a period of time sufficient to at least reduce the amount of calcium mineral present on said calcified aortic valve.    
     
     
         27 . The method according to  claim 26 , wherein said isolating step comprises activating said ventricular side aortic valve occlusion element followed by activating said coronary ostia and ascending aorta occlusion elements.  
     
     
         28 . The method according to  claim 26 , wherein said flushing comprises contacting said isolated calcified aortic valve with said acidic dissolution fluid and-removing fluid from said isolated calcified aortic valve.  
     
     
         29 . The method according to  claim 28 , wherein said method further comprises contacting said isolated calcified aortic valve with a pH elevating fluid.  
     
     
         30 . The method according to  claim 29 , wherein said pH elevating fluid is a buffer.  
     
     
         31 . The method according to  claim 29 , wherein said acidic dissolution fluid is contacted with the aortic side of said calcified aortic valve and said pH elevating fluid is contacted with the ventricular side of said calcified aortic valve.  
     
     
         32 . A system for increasing the aortic valve flow of a stenotic aortic valve, said system comprising: 
 (i) a device according to  claim 1;  and    (ii) a volume of stenosis dissolution fluid.    
     
     
         33 . The system according to  claim 32 , wherein said system further comprises a negative pressure element.  
     
     
         34 . The system according to  claim 32 , wherein said system further comprises a dissolution fluid attenuating fluid.  
     
     
         35 . The system according to  claim 32 , wherein said dissolution fluid is an acidic dissolution fluid.  
     
     
         36 . The system according to  claim 34 , wherein said dissolution fluid attenuating fluid is a pH elevating fluid.  
     
     
         37 . A kit for use in increasing the aortic valve flow of a stenotic aortic valve, said kit comprising: 
 a device according to  claim 1;  and    instructions for practicing the method of  claim 15 .    
     
     
         38 . The kit according to  claim 37 , wherein said kit further includes a stenotic dissolution fluid or reagents for use in producing the same.  
     
     
         39 . The kit according to  claim 38 , wherein said dissolution fluid is an acidic fluid.  
     
     
         40 . The kit according to  claim 37 , wherein said kit further includes a dissolution fluid attenuating fluid or reagents for use in producing the same.  
     
     
         41 . The kit according to  claim 40 , wherein said dissolution fluid attenuating fluid is a pH elevating fluid.  
     
     
         42 . The kit according to  claim 41 , wherein said attenuating fluid is a buffer.