Methods for enhancing fluid flow through an obstructed vascular site, and systems and kits for use in practicing the same

Abstract

Methods of enhancing fluid flow through a vascular site occupied by a vascular occlusion, as well as systems and kits for use in practicing the same, are provided. In practicing the subject methods, the vascular site is flushed simultaneously with a first dissolution fluid (e.g., an organic matter dissolution fluid and/or an inorganic matter dissolution fluid), and a second dissolution fluid attenuating fluid, where flushing is carried out in a manner such that only a surface of the vascular occlusion is contacted with the non-attenuated dissolution fluid. Examples of dissolution fluid/dissolution fluid attenuating fluid pairs include: (1) oxidizing agent fluid and fluid comprising oxidizable neutralizing agent; (2) surfactant fluid and phosphate buffered saline; (3) acidic solution and phosphate buffered saline; etc. 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 methods, systems and kits for practicing the same find use in the treatment of a variety of different vascular diseases characterized by the presence of vascular occlusions, including both partial and total occlusions.

1 . 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) a dissolution fluid; and  
 (ii) a dissolution fluid attenuating fluid;  
   for a period of time sufficient for fluid flow to be enhanced through said vascular site;    with the proviso that said simultaneous flushing occurs in a manner such that only a surface of said vascular occlusion is contacted with non-attenuated dissolution fluid and the remainder of said vascular site is not contacted with non-attenuated dissolution fluid;    whereby fluid flow is enhanced through said vascular site.    
     
     
         2 . The method according to  claim 1 , wherein said vascular occlusion at least comprises organic matter.  
     
     
         3 . The method according to  claim 1 , wherein said vascular occlusion at least comprises inorganic matter.  
     
     
         4 . The method according to  claim 1 , wherein said vascular occlusion comprises both organic and inorganic matter.  
     
     
         5 . The method according to  claim 1 , wherein said dissolution fluid is an organic matter dissolution fluid.  
     
     
         6 . The method according to  claim 1 , wherein said organic matter dissolution fluid comprises an active agent selected from the group consisting of enzymes, surfactants, oxidizing agents and thrombolytic agents.  
     
     
         7 . The method according to  claim 1 , wherein said dissolution fluid is an inorganic matter dissolution fluid.  
     
     
         8 . The method according to  claim 7 , wherein said inorganic matter dissolution fluid is an acidic dissolution fluid.  
     
     
         9 . The method according to  claim 1 , wherein said occlusion is a total occlusion.  
     
     
         10 . The method according to  claim 1 , wherein said occlusion is a partial occlusion.  
     
     
         11 . The method according to  claim 1 , wherein a catheter device is used to flush said surface of said vascular occlusion.  
     
     
         12 . The method according to  claim 11 , wherein said catheter device comprises at least three different lumens.  
     
     
         13 . The method according to  claim 1   1 , wherein said catheter device comprises at least four different lumens.  
     
     
         14 . A method of enhancing fluid flow through a vascular site occupied by an organic matter comprising vascular occlusion, said method comprising: 
 simultaneously flushing said vascular site with: 
 (i) an organic matter dissolution fluid; and  
 (ii) an organic matter dissolution fluid attenuating fluid;  
   for a period of time sufficient for fluid flow to be enhanced through said vascular site;    with the proviso that said simultaneous flushing occurs in a manner such that only a surface of said organic matter comprising vascular occlusion is contacted with non-attenuated organic matter dissolution fluid and the remainder of said vascular site is not contacted with non-attenuated organic matter dissolution fluid;    whereby fluid flow is enhanced through said vascular site.    
     
     
         15 . The method according to  claim 14 , wherein said organic matter dissolution fluid comprises an active agent selected from the group consisting of enzymes, surfactants, oxidizing and thrombolytic agents.  
     
     
         16 . The method according to  claim 14 , wherein said organic matter dissolution fluid attenuating agent is an aqueous fluid.  
     
     
         17 . The method according to  claim 14 , wherein said organic matter dissolution fluid comprises an oxidizing agent.  
     
     
         18 . The method according to  claim 17 , wherein said organic matter dissolution fluid attenuating agent comprises an aqueous buffer solution.  
     
     
         19 . The method according to  claim 18 , wherein said wherein said organic matter dissolution fluid comprises surfactant.  
     
     
         20 . The method according to  claim 14 , wherein said vascular occlusion is a total occlusion.  
     
     
         21 . The method according to  claim 14 , wherein said vascular occlusion is a partial occlusion.  
     
     
         22 . A method of enhancing fluid flow through a vascular site occupied by an inorganic matter comprising vascular occlusion, said method comprising: 
 simultaneously flushing said vascular site with: 
 (i) an inorganic matter dissolution fluid; and  
 (ii) an inorganic matter dissolution fluid attenuating fluid;  
   for a period of time sufficient for fluid flow to be enhanced through said vascular site;    with the proviso that said simultaneous flushing occurs in a manner such that only a surface of said inorganic matter comprising vascular occlusion is contacted with non-attenuated inorganic matter dissolution fluid and the remainder of said vascular site is not contacted with non-attenuated inorganic matter dissolution fluid;    whereby fluid flow is enhanced through said vascular site.    
     
     
         23 . The method according to  claim 22 , wherein said inorganic matter is a calcium phosphate mineral.  
     
     
         24 . The method according to  claim 22 , wherein said inorganic matter dissolution fluid is an acidic solution.  
     
     
         25 . The method according to  claim 24 , wherein said inorganic matter dissolution fluid attenuating fluid is a buffer solution.  
     
     
         26 . The method according to  claim 22 , wherein said vascular occlusion is a total occlusion.  
     
     
         27 . The method according to  claim 22 , wherein said vascular occlusion is a partial occlusion.  
     
     
         28 . A method of enhancing fluid flow through a vascular site occupied by vascular occlusion, said method comprising: 
 simultaneously flushing said vascular site with: 
 (i) a dissolution fluid that dissolves both organic and inorganic matter;  
   and 
 (ii) a dissolution fluid attenuating fluid;  
   for a period of time sufficient for fluid flow to be enhanced through said vascular site;    with the proviso that said simultaneous flushing occurs in a manner such that only a surface of said inorganic matter comprising vascular occlusion is contacted with non-attenuated dissolution fluid and the remainder of said vascular site is not contacted with non-attenuated dissolution fluid;    whereby fluid flow is enhanced through said vascular site.    
     
     
         29 . The method according to  claim 28 , wherein said dissolution fluid comprises an acid.  
     
     
         30 . The method according to  claim 28 , wherein said dissolution fluid comprises a surfactant.  
     
     
         31 . The method according to  claim 28 , wherein said dissolution fluid attenuating fluid is a buffer solution.  
     
     
         32 . The method according to  claim 28 , wherein said vascular occlusion is a total occlusion.  
     
     
         33 . The method according to  claim 28 , wherein said vascular occlusion is a partial occlusion.  
     
     
         34 . A system for use in enhancing fluid flow through a vascular site occupied by an vascular occlusion, said system comprising: 
 a means for simultaneously flushing said vascular site with a dissolution fluid and a dissolution fluid attenuating fluid;    a dissolution fluid; and    an dissolution fluid attenuating fluid.    
     
     
         35 . The system according to  claim 34 , wherein said means for simultaneously flushing said vascular site with a dissolution fluid and a dissolution attenuating fluid comprises two different fluid introducing means and a fluid aspiration means.  
     
     
         36 . The system according to  claim 34 , wherein said flushing means is a catheter means.  
     
     
         37 . The system according to  claim 34 , wherein said system further comprises: 
 (a) a manifold;    (b) a dissolution fluid reservoir;    (d) a dissolution fluid attenuating; and    (e) a source of negative pressure.    
     
     
         38 . The system according to  claim 34 , wherein said system further includes a balloon inflation means.  
     
     
         39 . The system according to  claim 38 , wherein said balloon inflation means is a syringe.  
     
     
         40 . The system according to  claim 34 , wherein said system further comprises a guidewire.  
     
     
         41 . A kit for use in enhancing fluid flow through a vascular site occupied by a vascular occlusion, said kit comprising: 
 a means for flushing said vascular site with a dissolution fluid and a dissolution fluid attenuating fluid; and    instructions for practicing the method of  claim 1 .    
     
     
         42 . The kit according to  claim 41 , wherein said kit further comprises a dissolution fluid or a precursor(s) thereof.  
     
     
         43 . The kit according to  claim 41 , wherein said kit further comprises a dissolution fluid attenuating fluid or precursors thereof.  
     
     
         44 . The kit according to  claim 41 , wherein said kit further comprises a guidewire.  
     
     
         45 . A lesion dissolution fluid comprising: 
 an acid; and    a surfactant.    
     
     
         46 . The fluid according to  claim 45 , wherein said fluid further comprises a salt.  
     
     
         47 . The fluid according to  claim 45 , wherein said acid is an inorganic acid.  
     
     
         48 . The fluid according to  claim 45 , wherein said inorganic acid is hydrogen chloride.  
     
     
         49 . The fluid according to  claim 45 , wherein said surfactant is selected from the group consisting of cationic surfactants, anionic surfactants, zwitterionic surfactants and nonionic surfactants.  
     
     
         50 . The fluid according to  claim 49 , wherein said surfactant is a cationic surfactant.  
     
     
         51 . The fluid according to  claim 50 , wherein said cationic surfactant is sodium dodecyl sulfate.