Entraining biological calculi

Abstract

A medical device for entraining biological stones during medical procedures for the fragmentation of urinary, biliary, pancreatic, and other biological calculi and safely removing them from the body. The device includes a guidewire having a longitudinally-extending wire core. A portion of the wire core more adjacent the distal end thereof than the proximal end thereof is wound to form a helical coil which tapers in diameter from a larger diameter end at the proximal end thereof to a smaller diameter end at the distal end thereof. At least a portion of the core forming said helical coil is made of a super-elastic deformable material which collapses upon retraction into a tubular sheath and which reforms into a coil upon deployment from the sheath.

1 . A medical device comprising a generally longitudinally-extending wire core, a portion of said core more adjacent the distal end thereof than the proximal end thereof being wound to form a helical coil which tapers in diameter from a larger diameter end at the proximal end thereof to a smaller diameter end at the distal end thereof, at least the portion of said core forming said helical coil being made of super-elastic deformable material.  
   
   
       2 .- 13 . (canceled)  
   
   
       14 . The medical device of  claim 1 , wherein said core comprises a super-elastic deformable material.  
   
   
       15 . The device of  claim 1 , wherein said super-elastic deformable material is an alloy comprising nickel and titanium.  
   
   
       16 . The device of  claim 15 , wherein the alloy consists of nickel, titanium, and chromium.  
   
   
       17 . (canceled)  
   
   
       18 . A medical device comprising: 
 a guidewire including a longitudinally-extending wire core, a portion of said core more adjacent the distal end thereof than the proximal end thereof being wound to form a helical coil which tapers in diameter from a larger diameter end at the proximal end thereof to a smaller diameter end at the distal end thereof, at least the portion of said core forming said helical coil being made of a super-elastic deformable material; and    a flexible tubular sheath surrounding a portion of and being movable axially relative to said guidewire,    the sheath having an inner diameter that is greater than the diameter of the guidewire other than a portion of said guidewire forming said helical coil, such that said coil deforms into a configuration having a maximum diameter not more than the inner diameter of said sheath upon retraction into the sheath and returns to a coil configuration having a maximum diameter greater than the outer diameter of said sheath upon withdrawal from the sheath.    
   
   
       19 . (canceled)  
   
   
       20 . A medical procedure comprising the steps of: 
 providing a medical device according to  claim 18  in a configuration in which the helical coil of the guide wire of said device is retracted into the tubular sheath of said device;    introducing the device in said configuration into a desired pathway within a body;    positioning the device in a desired location within said pathway;    moving the helical coil portion of the guidewire relative to the sheath such that the helical coil portion of the guide wire is withdrawn from the sheath and returns to a coil configuration and in which the coil engages the inner surface of the pathway.    
   
   
       21 . The procedure of  claim 20 , wherein a biological calculus is within said pathway and said procedure includes fragmentation of the calculus, including the steps of: 
 locating the biological calculus within the pathway;    placing at least a portion of the sheathed guidewire beyond the location of the calculus; and    moving the guidewire relative to the sheath such that the helical coil portion thereof is exposed from the distal end of the sheath and reforms into a helical coil configuration distally of the calculus.    
   
   
       22 . The procedure of  claim 20 , wherein the procedure further comprises the step of fragmenting a biological calculus located in a desired location in said pathway and distally to the coil that has engaged the inner surface of the pathway, using lithotripsy.  
   
   
       23 . The procedure of  claim 22 , wherein the lithotripsy comprises one of electrohydraulic, pneumatic pulse, acoustic shock wave, and laser lithotripsy.  
   
   
       24 . The medical device of  claim 1 , wherein at least a portion of the device includes a layer of radiopaque material.  
   
   
       25 . The medical device of  claim 24 , wherein the radiopaque material comprises gold, platinum, tantalum, tungsten, iridium, rhodium, rhenium, or an alloy of two or more radiopaque materials.  
   
   
       26 . The medical device of  claim 18 , wherein at least a portion of the flexible tubular sheath comprises a layer of a radiopaque material.  
   
   
       27 . The medical device of  claim 26 , wherein the radiopaque material comprises gold, platinum, tantalum, tungsten, iridium, rhodium, rhenium, or an alloy of two or more radiopaque material.  
   
   
       28 . (canceled)  
   
   
       29 . The medical device of  claim 1 , wherein a layer of a polymeric material substantially covers at least the portion of said core forming said helical coil.  
   
   
       30 . The medical device of  claim 29 , wherein a layer of a polymeric material substantially covers the outer surface of the wire core.  
   
   
       31 . The medical device of  claim 29 , wherein the polymeric material comprises a fluorinated polymer.  
   
   
       32 . The medical device of claim  4 , wherein the fluorinated polymer is polytetrafluoroethylene.  
   
   
       33 . The medical device of  claim 1 , wherein the wire core is about 50 cm to about  250  cm long.  
   
   
       34 . The medical device of  claim 33 , wherein the wire core is about 140 cm to about 220 cm long.  
   
   
       35 . The medical device of  claim 1  or  30 , wherein the wire core is about 0.015 inches (0.381 mm) to about 0.04 inches (1.016 mm) in width.  
   
   
       36 . The medical device of  claim 1  or  30 , wherein the proximal end of the helical coil has a diameter of about 0.2 cm to about 3.0 cm.  
   
   
       37 . The medical device of  claim 36 , wherein the proximal end of the helical coil has a diameter of about 0.5 cm to about 1.5 cm.  
   
   
       38 . The medical device of  claim 37 , wherein the proximal end of the helical coil has a diameter of about 0.7 cm to about 0.8 cm.  
   
   
       39 . The medical device of  claim 1 , wherein the helical coil comprises between about 5 turns and about 15 turns.  
   
   
       40 . The medical device of  claim 1 , wherein the distal end of the helical coil is about 2 cm to about 50 cm from the distal end of the device.  
   
   
       41 . The medical device of  claim 40 , wherein the distal end of the helical coil is about 10 cm to about 24 cm from the distal end of the device.  
   
   
       42 . The medical device of  claim 18 , wherein a layer of a polymeric material substantially covers at least the portion of said core forming said helical coil.  
   
   
       43 . The medical device of  claim 42 , wherein a layer of a polymeric material substantially covers the outer surface of the wire core.  
   
   
       44 . The medical device of  claim 42 , wherein the polymeric material comprises a fluorinated polymer.  
   
   
       45 . The medical device of  claim 44 , wherein the fluorinated polymer is polytetrafluoroethylene.  
   
   
       46 . The device of  claim 18 , wherein said super-elastic deformable material is an alloy comprising nickel and titanium.  
   
   
       47 . The device of  claim 46 , wherein the alloy consists essentially of nickel, titanium, and chromium.  
   
   
       48 . The medical device of  claim 18 , wherein the wire core is about 50 cm to about 250 cm long.  
   
   
       49 . The medical device of  claim 48 , wherein the wire core is about 140 cm to about 220 cm long.  
   
   
       50 . The medical device of  claim 18  or  42 , wherein the wire core is about 0.015 inches (0.381 mm) to about 0.04 inches (1.016 mm) in width.  
   
   
       51 . The medical device of  claim 18  or  42 , wherein the proximal end of the helical coil has a diameter of about 0.2 cm to about 3.0 cm.  
   
   
       52 . The medical device of  claim 51 , wherein the proximal end of the helical coil has a diameter of about 0.5 cm to about 1.5 cm.  
   
   
       53 . The medical device of  claim 52 , wherein the proximal end of the helical coil has a diameter of about 0.7 cm to about 0.8 cm.  
   
   
       54 . The medical device of  claim 18 , wherein the helical coil comprises between about 5 turns and about 15 turns.  
   
   
       55 . The medical device of  claim 18 , wherein the distal end of the helical coil is about 2 cm to about 50 cm from the distal end of the device.  
   
   
       56 . The medical device of  claim 55 , wherein the distal end of the helical coil is about 10 cm to about 24 cm from the distal end of the device.  
   
   
       57 . The medical device of  claim 18 , wherein at least a portion of the flexible tubular sheath comprises a layer of a radiopaque material.  
   
   
       58 . The medical device of  claim 57 , wherein the radiopaque material comprises gold, platinum, tantalum, tungsten, iridium, rhodium, rhenium, or an alloy of two or more radiopaque material.  
   
   
       59 . The medical device of  claim 18 , wherein a portion of the coil is covered with a radiopaque material.  
   
   
       60 . The medical device of  claim 57 , wherein the flexible tubular sheath is covered at its distal portion with a radiopaque material.  
   
   
       61 . The medical device of  claim 18 , wherein the coil portion of the guidewire fits into the flexible tubular sheath having an inner diameter about 0.005 inches (0.127 mm) greater than the coil portion of the guidewire.