Color-coded and sized loadable polymeric particles for therapeutic and/or diagnostic applications and methods ofpreparing and using the same

Abstract

Polymeric particles are provided for use in therapeutic and/or diagnostic procedures. The particles include poly[bis(trifluoroethoxy)phosphazene and/or a derivative thereof which may be present throughout the particles or within an outer coating of the particles. The particles may also include a core having a hydrogel formed from an acrylic-based polymer. Such particles may be provided to a user in specific selected sizes to allow for selective embolization of certain sized blood vessels or localized treatment with an active component agent in specific clinical uses. Particles of the present invention may further be provided as color-coded microspheres or nanospheres to allow ready identification of the sized particles in use. Such color-coded microspheres or nanospheres may further be provided in like color-coded delivery or containment devices to enhance user identification and provide visual confirmation of the use of a specifically desired size of microspheres or nanospheres.

What is claimed is: 
     
         1 . A polymeric particle comprising:
 a hydrogel core;   a first dye; and   a coating that comprises a polyphosphazene selected from poly[bis(2,2,2-trifluoroethoxy)]phosphazene or a derivative of poly[bis(2,2,2-trifluoroethoxy)]phosphazene;   wherein the polymeric particle are of sufficient size to occlude a blood vessel of a patient when a plurality of polymeric particles are administered to the patient.   
     
     
         2 . The polymeric particle of  claim 1 , wherein the first dye is in the hydrogel core and the polymeric particle comprises a second dye in the coating. 
     
     
         3 . The polymeric particle of  claim 1 , wherein the polyphosphazene has the formula: 
       
         
           
           
               
               
           
         
         where n is an integer that is at least 100 and 
         where R 1  to R 6  are selected from 2,2,2-trifluoroethoxy (OCH 2 CF 3 ), 2,2,3,3,3-pentafluoropropyloxy (OCH 2 CF 2 CF 3 ), 2,2,2,2′,2′,2′-hexafluoroisopropyloxy (OCH(CF 3 ) 2 ), 2,2,3,3,4,4,4-heptafluorobutyloxy (OCH 2 CF 2 CF 2 CF 3 ), 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyloxy (OCH 2 (CF 2 ) 7 CF 3 ), 2,2,3,3-tetrafluoropropyloxy (OCH 2 CF 2 CHF 2 ), 2,2,3,3,4,4-hexafluorobutyloxy (OCH 2 CF 2 CF 2 CF 3 ), 3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorooctyloxy (OCH 2 (CF 2 ) 7 CHF 2 ). 
       
     
     
         4 . The polymeric particle of  claim 3 , wherein n is about 4,000 to about 300,000. 
     
     
         5 . The polymeric particle of  claim 3 , wherein n is about 13,000 to about 30,000. 
     
     
         6 . The polymeric particle of  claim 1  having a diameter of about 1 μm to about 1,000 μm. 
     
     
         7 . The polymeric particle of  claim 1  having a diameter of about 200 μm to about 500 μm. 
     
     
         8 . The polymeric particle of  claim 1 , further comprising one or more active agents selected from steroids, hormones, nucleic acids, or anti-neoplastic agents. 
     
     
         9 . The polymeric particle of  claim 1 , further comprising barium sulfate as a contrast agent. 
     
     
         10 . The polymeric particle of  claim 9 , wherein the barium sulfate is located in the core. 
     
     
         11 . The polymeric particle of  claim 1 , further comprising a contrast agent and wherein the contrast agent is configured to allow imaging of the particles once the particles are administered to the patient. 
     
     
         12 . The polymeric particle of  claim 11 , wherein the contrast agent is barium sulfate. 
     
     
         13 . The polymeric particle of  claim 1 , wherein different dyes are used as markers for different particle sizes. 
     
     
         14 . A syringe containing a plurality of the polymeric particles of  claim 1 . 
     
     
         15 . A syringe comprising a colored tip and a plurality of the polymeric particles of  claim 1 , wherein the colored tip corresponds to a color of the first dye.