Confinement of kidney-stone fragments during lithotripsy

Abstract

The present invention improves significantly the success rate of lithotripsy and reduces the risk of tissue damage, by injecting temporary plugs in front and behind a concretion (for extracorporeal lithotripsy) or behind a concretion (for intracorporeal lithotripsy). One aspect of the present invention relates to injecting an inverse thermosensitive polymer solution into a lumen, thereby preventing the migration of a concretion, or its fragments, upon extracorporeal or intracorporeal lithotripsy.

1 . A method of lithotripsy comprising the steps of: 
 injecting a first composition, comprising an inverse thermosensitive polymer, into a lumen of a mammal, at a first distance from a concretion, wherein said first composition does not contact said concretion;    optionally injecting a second composition, comprising an inverse thermosensitive polymer, into said lumen, at a second distance from said concretion, wherein said second composition is placed on the approximately opposite side of said concretion relative to said first composition, wherein said second composition does not contact said concretion; and    directing energy to said concretion causing the fragmentation of said concretion into a plurality of fragments.    
   
   
       2 . The method of  claim 1 , wherein said inverse thermosensitive polymer is a block copolymer, random copolymer, graft polymer, or branched copolymer.  
   
   
       3 . The method of  claim 1 , wherein said inverse thermosensitive polymer is a block polymer or a branched copolymer.  
   
   
       4 . The method of  claim 1 , wherein said inverse thermosensitive polymer is an optionally purified poloxamer or poloxamine.  
   
   
       5 . The method of  claim 1 , wherein said inverse thermosensitive polymer is optionally purified and selected from the group consisting of poloxamine 1107, poloxamine 1307, poloxamer 338 and poloxamer 407.  
   
   
       6 . The method of  claim 1 , wherein said inverse thermosensitive polymer is an optionally purified poloxamer 407.  
   
   
       7 . The method of  claim 1 , wherein said inverse thermosensitive polymer solution has a transition temperature of between about 10° C. and 40° C.  
   
   
       8 . The method of  claim 1 , wherein said inverse thermosensitive polymer solution has a transition temperature of between about 15° C. and 30° C.  
   
   
       9 . The method of  claim 1 , wherein said inverse thermosensitive polymer solution has a transition temperature of about 25° C.  
   
   
       10 . The method of  claim 1 , wherein said first distance is between about 1 cm and about 5 cm.  
   
   
       11 . The method of  claim 1 , wherein said first distance is between about 2 cm and about 4 cm.  
   
   
       12 . The method of  claim 1 , wherein said first distance is about 3 cm.  
   
   
       13 . The method of  claim 1 , wherein said second distance is between about 1 cm and about 5 cm.  
   
   
       14 . The method of  claim 1 , wherein said second distance is between about 2 cm and about 4 cm.  
   
   
       15 . The method of  claim 1 , wherein said second distance is about 3 cm.  
   
   
       16 . The method of  claim 1 , wherein said composition is injected into said lumen through a percutaneous access device.  
   
   
       17 . The method of  claim 1 , wherein said composition is injected into said lumen through a catheter or a syringe.  
   
   
       18 . The method of  claim 17 , wherein the catheter is a dual lumen catheter or a triple lumen catheter.  
   
   
       19 . The method of  claim 1 , wherein said energy is an acoustic shock wave, a pneumatic pulsation, an electrical hydraulic shock wave, or a laser beam.  
   
   
       20 . The method of  claim 1 , wherein said lumen is, or is part of, a kidney, a gall bladder, a ureter, a urinary bladder, a pancreas, a salivary gland, a small intestine or a large intestine.  
   
   
       21 . The method of  claim 1 , wherein said lumen is, or is part of, the ureter or kidney.  
   
   
       22 . The method of  claim 1 , wherein said concretion is a kidney stone, pancreatic stone, salivary stone, or biliary stone.  
   
   
       23 . The method of  claim 1 , wherein said concretion is a kidney stone.  
   
   
       24 . The method of  claim 1 , wherein said mammal is a human.  
   
   
       25 . The method of  claim 1 , wherein said composition comprises about 5% to about 30% of said inverse thermosensitive polymer.  
   
   
       26 . The method of  claim 1 , wherein said composition comprises about 10% to about 25% said inverse thermosensitive polymer.  
   
   
       27 . The method of  claim 1 , wherein said composition comprising an inverse thermosensitive polymer further comprises a contrast-enhancing agent.  
   
   
       28 . The method of  claim 27 , wherein said contrast-enhancing agent is selected from the group consisting of radiopaque materials, paramagnetic materials, heavy atoms, transition metals, lanthanides, actinides, dyes, and radionuclide-containing materials.  
   
   
       29 . The method of  claim 1 , wherein the inverse thermosensitive polymer has a polydispersity index from about 1.5 to 1.0.  
   
   
       30 . The method of  claim 1 , wherein the inverse thermosensitive polymer has a polydispersity index from about 1.2 to 1.0.  
   
   
       31 . The method of  claim 1 , wherein the inverse thermosensitive polymer has a polydispersity index from about 1.1 to 1.0.  
   
   
       32 . The method of  claim 1 , wherein said inverse thermosensitive polymer is an optionally purified poloxamer or poloxamine; and said inverse thermosensitive polymer solution has a transition temperature of between about 10° C. and 40° C.  
   
   
       33 . The method of  claim 1 , wherein said inverse thermosensitive polymer is an optionally purified poloxamer or poloxamine; and said inverse thermosensitive polymer solution has a transition temperature of between about 15° C. and 30° C.  
   
   
       34 . The method of  claim 1 , wherein said inverse thermosensitive polymer is an optionally purified poloxamer or poloxamine; and said inverse thermosensitive polymer solution has a transition temperature of about 25° C.  
   
   
       35 . The method of  claim 1 , wherein said energy is an acoustic shock wave, a pneumatic pulsation, an electrical hydraulic shock wave, or a laser beam; and said lumen is, or is part of, a kidney, a gall bladder, a ureter, a urinary bladder, a pancreas, a salivary gland, a small intestine or a large intestine.  
   
   
       36 . The method of  claim 1 , wherein said inverse thermosensitive polymer is optionally purified and selected from the group consisting of poloxamine 1107, poloxamine 1307, poloxamer 338 and poloxamer 407; and said lumen is, or is part of, a kidney, a gall bladder, a ureter, a urinary bladder, a pancreas, a salivary gland, a small intestine or a large intestine.  
   
   
       37 . The method of  claim 1 , wherein said inverse thermosensitive polymer is optionally purified poloxamer 407; and said lumen is, or is part of, the ureter or kidney.  
   
   
       38 . The method of  claim 1 , wherein said inverse thermosensitive polymer is optionally purified and selected from the group consisting of poloxamine 1107, poloxamine 1307, poloxamer 338 and poloxamer 407; wherein said energy is an acoustic shock wave, a pneumatic pulsation, an electrical hydraulic shock wave, or a laser beam; and said lumen is, or is part of, a kidney, a gall bladder, a ureter, a urinary bladder, a pancreas, a salivary gland, a small intestine or a large intestine.  
   
   
       39 . The method of  claim 1 , wherein said inverse thermosensitive polymer is an optionally purified poloxamer or poloxamine; said inverse thermosensitive polymer solution has a transition temperature of between about 10° C. and 40° C.; said energy is an acoustic shock wave, a pneumatic pulsation, an electrical hydraulic shock wave, or a laser beam; and said lumen is, or is part of, a kidney, a gall bladder, a ureter, a urinary bladder, a pancreas, a salivary gland, a small intestine or a large intestine.  
   
   
       40 . The method of  claim 1 , wherein said inverse thermosensitive polymer is an optionally purified poloxamer or poloxamine; wherein said inverse thermosensitive polymer solution has a transition temperature of between about 15° C. and 30° C.; said energy is an acoustic shock wave, a pneumatic pulsation, an electrical hydraulic shock wave, or a laser beam; and said lumen is, or is part of, a kidney, a gall bladder, a ureter, a urinary bladder, a pancreas, a salivary gland, a small intestine or a large intestine.  
   
   
       41 . The method of  claim 1 , wherein said inverse thermosensitive polymer is an optionally purified poloxamer or poloxamine; said inverse thermosensitive polymer solution has a transition temperature of about 25° C.; said energy is an acoustic shock wave, a pneumatic pulsation, an electrical hydraulic shock wave, or a laser beam; and said lumen is, or is part of, a kidney, a gall bladder, a ureter, a urinary bladder, a pancreas, a salivary gland, a small intestine or a large intestine.  
   
   
       42 . The method of  claim 1 , wherein said inverse thermosensitive polymer is an optionally purified poloxamer or poloxamine; said inverse thermosensitive polymer solution has a transition temperature of between about 10° C. and 40° C.; said energy is an electrical hydraulic shock wave; and said lumen is, or is part of, the ureter or kidney.