Catheter systems and methods for their use in the treatment of calcified vascular occlusions

Abstract

Catheter systems and methods for their use in enhancing fluid flow through a vascular site occupied by a vascular occlusion are provided. The subject catheter systems include at least an aspiration catheter and at least one of a total occlusion insert catheter and a partial occlusion insert catheter, where the insert catheters are capable of being slidably moved in the lumen of the aspiration catheter. In practicing the subject methods, a surface of the vascular occlusion is flushed with an acidic dissolution fluid using the subject catheter systems for a period of time sufficient for fluid flow through the vascular site to be enhanced, e.g. increased or established. The subject catheter systems and methods find use in the treatment of a variety of different vascular diseases characterized by the presence of calcified vascular occlusions, including peripheral and coronary vascular diseases.

What is claimed is:  
     
         1 . A catheter system comprising: 
 (a) an aspiration catheter comprising an elongated tube having an aspiration lumen ending in an open distal end and an inflatable balloon at said distal end; and    (b) at least one of: 
 (i) a total occlusion catheter insert comprising an elongated tube having an open distal end; and  
 (ii) a partial occlusion catheter insert comprising an elongated tube having a sealed distal end, an inflatable balloon at said distal end and at least one infusion port proximal to said inflatable balloon 
 wherein said total and partial occlusion catheter inserts are capable of being slidably positioned within said aspiration catheter to produce an annular space at the distal end of said aspiration catheter through which fluid may flow.  
 
   
     
     
         2 . The catheter system according to  claim 1 , wherein said system comprises both said partial and total occlusion catheter insert.  
     
     
         3 . The catheter system according to  claim 1 , wherein said aspiration catheter further comprises a guidewire lumen separate from said aspiration lumen.  
     
     
         4 . A coaxial catheter assembly comprising: 
 (a) an aspiration catheter comprising an elongated tube having an aspiration lumen ending in an open distal end and an inflatable balloon at said distal end; and    (b) one of: 
 (i) a total occlusion catheter insert comprising an elongated tube having an open distal end; or  
 (ii) a partial occlusion catheter insert comprising an elongated tube having a sealed distal end, an inflatable balloon at said distal end and at least one infusion port proximal to said inflatable balloon  
   slidably positioned within said aspiration lumen of said aspiration catheter in a manner such that an annular space through which fluid may flow is present at the distal end of said aspiration catheter.    
     
     
         5 . The coaxial catheter assembly according to  claim 4 , wherein said total occlusion catheter insert is slidably positioned within said aspiration lumen.  
     
     
         6 . The coaxial catheter assembly according to  claim 4 , wherein said partial occlusion catheter is slidably positioned within said aspiration lumen.  
     
     
         7 . A method of enhancing fluid flow through a vascular site occupied by a vascular occlusion, said method comprising: 
 flushing a surface of said vascular occlusion with an acidic dissolution fluid for a period of time sufficient for fluid flow to be enhanced through said vascular site; 
 whereby fluid flow is established through said vascular site.  
   
     
     
         8 . The method according to  claim 7 , wherein said vascular occlusion comprises calcium.  
     
     
         9 . The method according to  claim 7 , wherein said occlusion is a total occlusion.  
     
     
         10 . The method according to  claim 7 , wherein said occlusion is a partial occlusion.  
     
     
         11 . The method according to  claim 7 , wherein a coaxial catheter assembly according to  claim 4  is used to flush said surface of said vascular occlusion.  
     
     
         12 . The method according to  claim 11 , wherein said coaxial catheter assembly is the assembly according, to  claim 5 .  
     
     
         13 . The method according to  claim 11 , wherein said coaxial catheter assembly is the assembly according to  claim 6 .  
     
     
         14 . A method of flushing a vascular site with a solution, said method comprising: 
 introducing and removing said solution from said vascular site with a coaxial catheter assembly according to  claim 4 .    
     
     
         15 . The method according to  claim 14 , wherein said coaxial catheter assembly is the assembly according to  claim 5 .  
     
     
         16 . The method according to  claim 14 , wherein said coaxial catheter assembly is the assembly according to  claim 6 .  
     
     
         17 . A system for enhancing fluid flow through a vascular site occupied by a vascular occlusion, said system comprising: 
 (a) a coaxial catheter assembly according to  claim 4;     (b) a manifold;    (c) an acidic fluid dissolution reservoir in fluid communication the insert catheter of said coaxial catheter assembly; and    (d) a source of negative pressure in fluid communication with said aspiration lumen of said coaxial catheter assembly.    
     
     
         18 . The system according to  claim 17 , wherein said system further includes a balloon inflation means.  
     
     
         19 . The system according to  claim 18 , wherein said balloon inflation means is a syringe.  
     
     
         20 . The system according to  claim 17 , wherein said system further comprises a guidewire.  
     
     
         21 . A kit for use in enhancing fluid flow through a vascular site occupied by a vascular occlusion, said kit comprising: 
 a catheter system according to  claim 1 .    
     
     
         22 . The kit according to  claim 21 , wherein said kit further comprises a guidewire.  
     
     
         23 . The kit according to  claim 21 , wherein said kit further comprises an imaging agent.  
     
     
         24 . The kit according to  claim 21 , wherein said kit further comprises an acidic dissolution solution.  
     
     
         25 . A kit for use in enhancing fluid flow through a vascular site occupied by a vascular occlusion, said kit comprising: 
 (a) a catheter system according to  claim 1;     (b) an acidic dissolution solution; and    (c) a guidewire.    
     
     
         26 . The kit according to  claim 25 , wherein said kit further comprises a washing solution.  
     
     
         27 . The kit according to  claim 25 , wherein said kit further comprises a surfactant solution.  
     
     
         28 . The kit according to  claim 25 , wherein said kit further comprises an imaging agent.  
     
     
         29 . An acidic dissolution fluid consisting essentially of: 
 hydrogen chloride in a concentration ranging from about 0.01 to 1.0 N; and water.    
     
     
         30 . The solution according to  claim 29 , wherein said solution further consists of a salt.  
     
     
         31 . The solution according to  claim 30 , wherein said salt is NaCl.  
     
     
         32 . The solution according to  claim 31 , wherein said NaCl is present in a concentration ranging from about 0.01 to 0.1 M.