Compressible intravascular embolization particles and related methods and delivery systems

Abstract

The present invention relates to substantially compressible, spherical porous embolization particles, including methods of making and using the particles. Further, the invention relates to embolization delivery systems for the introduction of the particle into the vascular luer.

1 . A compressible embolization particle comprising a substantially spherical porous particle having pores that extend to the surface of said particle wherein said particle has a diameter ranging from about 1,000 microns to about 10,000 microns when hydrated and fully expanded.  
   
   
       2 . The particle of  claim 1 , wherein the particle has a diameter ranging from about 2,000 microns to about 4,500 microns when hydrated and fully expanded.  
   
   
       3 . The particle of  claim 1 , wherein the particle has a diameter ranging from about 3,000 microns to about 4,000 microns when hydrated and fully expanded.  
   
   
       4 . The particle of  claim 1 , wherein the particle comprises a PVA polymer.  
   
   
       5 . The particle of  claim 1 , wherein said particle is hydrated.  
   
   
       6 . The particle of  claim 5 , wherein said particle can be compressed in one dimension to about 80% of the diameter of the hydrated particle.  
   
   
       7 . The particle of  claim 5 , wherein said particle can be compressed in one dimension to about 25% of the diameter of the hydrated particle.  
   
   
       8 . The particle of  claim 1 , wherein the surface or interior pores of a dehydrated particle can have a diameter of 50 microns or more.  
   
   
       9 . The particle of  claim 1 , wherein the surface or interior pores of a dehydrated particle can have a diameter of 100-microns or more.  
   
   
       10 . The particle of  claim 1 , further comprising a porous annular ring around said particle.  
   
   
       11 . An embolization device comprising the embolization particle of  claim 1  and a catheter having a lumen to receive said particle.  
   
   
       12 . The device of  claim 11 , wherein the embolization particle is disposed in the lumen of said catheter.  
   
   
       13 . The device of  claim 12 , further comprising a 3-way connection component operably coupled to the catheter, and two syringes operably coupled to the 3-way connection component.  
   
   
       14 . A method of embolization comprising: 
 positioning a distal portion of the embolization device of  claim 12  in proximity to a target area of a blood vessel, and    ejecting the particle from the lumen of said embolization device such that the particle is positioned in the target area.    
   
   
       15 . The method of  claim 14 , wherein the particle expands from its compressed state to an expanded state upon ejection from said lumen.  
   
   
       16 . The method of  claim 15 , wherein the non-compressed particle has a diameter that is greater than an inner diameter of the target area of the blood vessel.  
   
   
       17 . The method of  claim 16 , wherein the particle in the expanded state is substantially fixed in position in the vessel.  
   
   
       18 . A method of loading an embolization particle into a catheter comprising: 
 positioning an embolization particle of  claim 1  in a luer hub of a catheter;    coupling a syringe containing hydration fluid to the luer hub;    operating the syringe to urge the embolization particle out of the luer hub and into the catheter;    removing the syringe from the luer hub; and    urging the embolization particle through the catheter and into a target area of a patient with a guidewire.    
   
   
       19 . A method of loading an embolization particle into a catheter comprising: 
 positioning an embolization particle of  claim 1  in a luer hub of a catheter;    coupling a three-way stopcock to the luer hub, wherein the stopcock is coupled to a first and a second syringe, wherein one or both of the syringes initially contain hydration fluid;    operating the first syringe to urge the embolization particle out of the luer hub and into the catheter; and    operating the second syringe to urge the embolization particle through the catheter and into a target area of a vessel.    
   
   
       20 . A method of embolization comprising 
 providing at least one embolization particle of  claim 1;     urging the embolization particle through a catheter wherein the particle is in a compressed state; and    positioning the embolization particle in a target vascular area, wherein the particle expands to an expanded state upon exiting the catheter.    
   
   
       21 . The method of  claim 20 , wherein the urging of the particle through the catheter is a guidewire.  
   
   
       22 . The method of  claim 20 , wherein the urging of the particle through the catheter comprises applying fluid pressure to the particle.  
   
   
       23 . A method of embolization comprising: 
 positioning a first embolization device in a target vascular area; and    positioning a second embolization device in proximity to the first embolization device, wherein at least one of said embolization devices comprise the embolization particle of  claim 1 .    
   
   
       24 . A method of making a compressible embolization particle, comprising: 
 mixing polyvinyl alcohol (“PVA”), a porogen, and a gas to form a foam; and    injecting the foam into a mold.    
   
   
       25 . The method of  claim 24 , wherein the mold is a hollow sphere formed from two halves of a sphere.  
   
   
       26 . The method of  claim 24 , further comprising trimming the annular ring formed at the junction of said two halves.