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

Abstract

Catheter devices and methods for their use in enhancing fluid flow through a vascular site occupied by a vascular occlusion are provided. The subject catheter devices include at least a first, second and third lumen, where: (a) the first lumen is used for delivery of an acidic dissolution solution to the vascular site; (b) the second lumen is used for delivery of a buffer solution to the vascular site; and (c) the third lumen is used for removal of fluid from the vascular site. In many preferred embodiments, the first, second and third lumens are coaxial. In practicing the subject methods, the vascular site is flushed simultaneously with an acidic dissolution fluid and a buffer solution, where flushing is carried out in a manner such that only a surface of the vascular occlusion is contacted with the acidic dissolution fluid and the remainder of the vascular site is not contacted with fluid having a pH that is lower than about 4. Flushing is carried out in this manner for a period of time sufficient for fluid flow through the vascular site to be enhanced, e.g. increased or established. The subject catheter devices 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.

1 . A catheter device comprising: 
 first, second and third lumens, wherein at least one of said lumens is fabricated from a material sufficient for delivery of an acidic dissolution solution; and    a first vascular occlusion means.    
     
     
         2 . The catheter device according to  claim 1 , wherein at least two of said lumens are coaxial.  
     
     
         3 . The catheter device according to  claim 1 , wherein said first, second and third lumens are coaxial.  
     
     
         4 . The catheter device according to  claim 3 , wherein said first lumen is present in a first fluid delivery member having a distal end, wherein said first fluid delivery member is movable relative to said second and third lumens.  
     
     
         5 . The catheter device according to  claim 3 , wherein said second lumen is present in a second fluid delivery member, where said second fluid delivery member is movable relative to said third lumen.  
     
     
         6 - 12 . (canceled).  
     
     
         13 . 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) a second elongated tube coaxially positioned inside of said aspiration catheter; and    (c) 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 at least said total and partial occlusion catheter inserts are capable of being slidably positioned within said second elongated tube to produce an annular space at the distal end of said elongated tube through which fluid may flow.    
     
     
         14 . The catheter system according to  claim 13 , wherein said system comprises both said partial and total occlusion catheter inserts.  
     
     
         15 . The catheter system according to  claim 13 , wherein at least one of said elements (a), (b) and (c) further comprises a separate guidewire lumen.  
     
     
         16 . The catheter system according to  claim 13 , wherein said aspiration catheter is in fluid communication with a negative pressure source.  
     
     
         17 . The catheter system according to  claim 13 , wherein said second elongate tubular member is in fluid communication with a buffer solution source.  
     
     
         18 . The catheter system according to  claim 13 , wherein said catheter inserts are in fluid communication with an acidic solution source.  
     
     
         19 . A method of enhancing fluid flow through a vascular site occupied by a vascular occlusion, said method comprising: 
 simultaneously flushing said vascular site with: 
 (i) an acidic dissolution fluid; and  
 (ii) a buffer solution;  
 for a period of time sufficient for fluid flow to be enhanced through said vascular site;  
   wherein said simultaneous flushing occurs in a manner such that only a surface of said vascular occlusion is contacted with said acidic dissolution fluid and the remainder of said vascular site is not contacted with solution having a pH of less than about 4;    whereby fluid flow is enhanced through said vascular site.    
     
     
         20 .- 33 . (canceled).