Torqueable soft tip medical device and method of usage

Abstract

A medical device or intravascular device, and methods of use. The devices may be tubular and may have a flexible polymer tip The body may be nitinol and may have cuts part way through along its length to facilitate bending The device may have a liner which may extend through the tip or form the tip The device may have markers readily visible on an X-ray viewer during insertion. The tip may have an anti-collapsing structure and may be shaped before use to perform a medical procedure such as treating an aneurysm. The device may have a strong fiber through it for complete removal. The method may include selecting the device, bending the tip, setting the shape, and inserting the device into the patient's anatomy. The shape of the tip may be set by heating with steam and then removing a mandrel.

What is claimed is:  
     
         1 . A medical device comprising: 
 a body having a proximal end and a distal end, said body having a plurality of cuts part way through said body; and    a tip extending from said distal end of said body, said tip substantially comprising a non-metallic material    
     
     
         2 . The device of  claim 1 , said tip being more flexible in bending than said body.  
     
     
         3 . The device of  claim 1:   said tip having a length that is greater than one millimeter; and    said tip having a length that is less than 1500 millimeters.    
     
     
         4 . The device of  claim 1:   said tip having a length that is greater than 10 millimeters, and said tip having a length that is less than 40 millimeters    
     
     
         5 . The device of  claim 1:   said tip having an outside diameter that is greater than 0.01 inches; and    said tip having an outside diameter that is less than 0.5 inches.    
     
     
         6 . The device of  claim 1:   said tip having an outside diameter that is greater than 0.030 inches; and    said tip having an outside diameter that is less than 0 040 inches.    
     
     
         7 . The device of  claim 1:   said tip having an outside diameter that is greater than 0.020 inches; and    said tip having an outside diameter that is less than 0 030 inches.    
     
     
         8 . The device of  claim 1:   said tip having an outside diameter that is greater than 0 015 inches; and    said tip having an outside diameter that is less than 0.025 inches.    
     
     
         9 . The device of  claim 1 , said tip being configured to be custom shaped by a person who will operate said device to perform a medical procedure.  
     
     
         10 . The device of  claim 1 , said body being substantially comprised of metal.  
     
     
         11 . The device of  claim 10 , said metal being super-elastic nitinol  
     
     
         12 . The device of  claim 1:   said body being substantially tubular; and    the device further comprising a substantially tubular liner    
     
     
         13 . The device of claim  12 : 
 said liner extending at least from said proximal end to said distal end; and    said liner further extending distal to said body.    
     
     
         14 . The device of  claim 13 , said tip substantially comprising said liner.  
     
     
         15 . The device of  claim 13 , said liner being inside said body.  
     
     
         16 . The device of claim  13 : 
 said tip further comprising a substantially tubular end sleeve; and    said end sleeve substantially comprising polymer.    
     
     
         17 . The device of claim  16 : 
 said end sleeve having a distal end;    said liner terminating substantially proximal to said distal end of said end sleeve.    
     
     
         18 . The device of  claim 1:   further comprising a substantially tubular liner and said body being inside said liner    
     
     
         19 . The device of  claim 1:   said body being substantially tubular;    the device further comprising a first liner and a second liner;    said first liner being inside said body; and    said body being inside said second liner.    
     
     
         20 . The device of  claim 19 . said device further having an end sleeve; 
 said end sleeve being between said first liner and said second liner.    
     
     
         21 . The device of  claim 1 , said tip further comprising an anti-collapsing structure.  
     
     
         22 . The device of  claim 21 , said anti-collapsing structure comprising at least one groove.  
     
     
         23 . The device of  claim 21 , said anti-collapsing structure comprising a coil  
     
     
         24 . The device of claim  21 : 
 said anti-collapsing structure comprising a coil; and    said coil being at least partially in a groove.    
     
     
         25 . The device of  claim 21 , said anti-collapsing structure comprising a braid.  
     
     
         26 . The device of  claim 1 , said device comprising at least one marker.  
     
     
         27 . The device of  claim 1 , said device comprising two markers.  
     
     
         28 . A medical device having a tensile strength, the device comprising: 
 a body having a proximal end and a distal end, said body having a plurality of cuts part way through said body, and    a fiber extending through said body, said fiber being configured to increase the tensile strength of the device.    
     
     
         29 . The device of  claim 28 , said fiber substantially comprising one or more materials selected from the group consisting of: polymers, metals, carbon fibers, and ceramic fibers.  
     
     
         30 . The device of claim  28 : 
 the device further comprising at least one substantially tubular liner;    said liner extending from said proximal end at least to said distal end;    said fiber being located between said body and said liner.    
     
     
         31 . The device of  claim 30 , said fiber being arranged substantially in a zigzag configuration.  
     
     
         32 . A method of treating a patient with a tubular medical device, the patient having anatomy, the method comprising the steps of: 
 selecting a medical device, the device having a flexible tip;    shaping the tip, said shaping comprising bending, and    inserting the device into the anatomy, said inserting comprising axially translating the device, rotating the device, and monitoring the distal end.    
     
     
         33 . The method of  claim 32 , the device having: 
 a body having a proximal end and a distal end, the body having a plurality of cuts part way through the body; and    the tip extending from the distal end of the body, the tip substantially comprising a non-metallic material.    
     
     
         34 . The method of  claim 32  further comprising the step, after said shaping, of setting the shape of the tip.  
     
     
         35 . The method of  claim 34  said setting the shape comprising heating the tip.  
     
     
         36 . The method of  claim 32  the device being substantially tubular and comprising at least one substantially tubular liner, the liner extending from the proximal end to the distal end.  
     
     
         37 . The method of  claim 32 , the device being substantially tubular, the method further comprising the step, after said shaping, of removing a mandrel from the tip.  
     
     
         38 . The method of  claim 32  further comprising the step, after said inserting, of performing a medical procedure using the device.  
     
     
         39 . The method of  claim 39 , the procedure comprising treating an aneurysm.  
     
     
         40 . The method of  claim 32 , the tip having at lest one marker, said monitoring comprising observing the marker  
     
     
         41 . The method of  claim 32 , further comprising the step of removing the device, the device having a fiber running substantially through the device, the fiber being configured to assure complete removal of the device.