Gynecologic embolotherapy methods

Abstract

This invention is directed to novel methods for gynecologic embolotherapy. The methods directly access the blood vessels to be embolized transcervically rather than arterially. The methods provide precise directed delivery of embolizing compositions, and are particularly suited for treating uterine fibroids. Kits containing one or more devices for transcervical injection and an embolizing composition are also provided. In a preferred embodiment, fluid embolizing compositions are used. In a more preferred embodiment, these fluid embolic compositions comprise a biocompatible polymer, a biocompatible solvent and a biocompatible water insoluble contrast agent. In a most preferred embodiment, the contrast agent is characterized by having an average particle size of about 10 μm or less.

1 - 14 . (canceled)  
   
   
       15 . A kit of parts particularly adapted for carrying out gynecological embolization comprising: 
 (a) a hysteroscope which allows catheter insertion through the cervix and into the uterus and visualization of the uterine wall;    (b) one or more catheters capable of being inserted through the cervix and into the uterus and thereafter penetrating a blood vessel to be embolized;    (c) at least one of the one or more catheters capable of delivering an embolic composition to the blood vessel to be embolized and is compatible with the embolic composition; and    (d) an embolic composition comprising a chemically inert biocompatible polymer a biocompatible contrast agent and a biocompatible solvent comprising an organic material liquid.    
   
   
       16 . (canceled)  
   
   
       17 . The kit of  claim 15  wherein the catheter capable of penetrating the blood vessel to be embolized is needle tipped.  
   
   
       18 . The kit of  claim 15  wherein one catheter is capable of both penetrating the blood vessel and delivering the embolic composition.  
   
   
       19 . (canceled)  
   
   
       20 . The kit of  claim 15  wherein the embolic composition is a fluid embolizing composition comprising: 
 (a) from about 2.5 to about 8.0 weight percent of a chemically inert biocompatible polymer;    (b) from about 10 to about 40 weight percent of a water insoluble, biocompatible contrast agent having an average particle size of about 10 μm or less; and    (c) from about 52 to about 87.5 weight percent of a biocompatible solvent comprising an organic material liquid:    wherein the weight percent of the polymer, contrast agent and biocompatible solvent is based on the total weight of the complete composition.    
   
   
       21 . The kit according to  claim 20  wherein said biocompatible solvent is selected from the group consisting of dimethylsulfoxide, ethanol and acetone.  
   
   
       22 . The kit according to  claim 21  wherein said biocompatible solvent is dimethylsulfoxide.  
   
   
       23 . The kit according to  claim 20  wherein said water insoluble contrast agent is the group consisting of tantalum, tantalum oxide, tungsten and barium sulfate.  
   
   
       24 . The kit according to  claim 23  wherein said contrast agent is tantalum.  
   
   
       25 . The kit according to  claim 20  wherein said biocompatible polymer is the group consisting of cellulose acetates, ethylene vinyl alcohol copolymers, hydrogels, polyacrylonitrile, polyvinylacetate, cellulose acetate butyrate, nitrocellulose, copolymers of urethane/carbonate, copolymers of styrene/maleic acid, and mixtures thereof.  
   
   
       26 . The kit according to  claim 25  wherein said biocompatible polymer is an ethylene and vinyl alcohol copolymer.  
   
   
       27 . The kit according to  claim 26  wherein said contrast agent is a particulate and has an average particle size of from 1 to 10 microns.