Gel composition for filling a breast milk duct prior to surgical excision of the duct or other breast tissue

Abstract

The invention is a gel composition for delivery to a breast milk duct prior to surgical excision of breast tissue including cancerous lesions. The invention also provides methods of mapping all or nearly all of a breast milk duct prior to surgical excision of breast tissue, and method of identifying part or all of a breast duct or ducts as a surgical aide to a breast surgeon. Kits to support these methods and including these compositions are also provided.

1 - 22 . (canceled)  
     
     
         23 . A method of treating a patient at risk for or having a precancer or cancer of a breast duct, said method comprising the following steps: 
 administering to a breast duct through a ductal orifice a biocompatible composition comprising; a polymer that has a solubility greater than 0.5 grams per 100 ml of solvent, a molecular weight in a range of between about 1 and 500 kilo Daltons and a weight/weight ratio of polymer to solvent in a range of between about 0.5:100 to 100:0.5, and further comprising a therapeutic additive; wherein said composition is a liquid in a solvent and undergoes a gel transition inside said breast duct within about 30 minutes of administration of said composition to said breast duct, and    delivering said therapeutic additive in said composition to precancerous or cancerous breast duct tissue and surrounding breast tissue after said composition undergoes a gel transition inside said breast duct;    wherein said therapeutic additive in said biocompatible composition that has undergone a gel transition provides treatment of a precancer or cancer of said breast duct.    
     
     
         24 . A composition of  claim 23 , wherein the polymer is water soluble and comprises a polyethylene polypropylene glycol block copolymer.  
     
     
         25 . A composition of  claim 23 , wherein the solvent is water, wherein the polymer selected from the group consisting of alkyl celluloses, hydroxyalky methyl celluloses, hyaluronic acid, sodium chondroitin sulfate, polyacrylic acid, polyacrylamide, polycyanolacrylates, methyl methacrylate polymers, 2-hydroxyethyl methacrylate polymers, cyclodextrin, polydextrose, dextran, gelatin, polygalacturonic acid, polyvinyl alcohol, polyvinyl pyrrolidone, polyalkylene glycols, and polyethylene oxide, and wherein the composition undergoes a gel transition between about 28° C. and 41° C.  
     
     
         26 . A biocompatible composition as in  claim 23 , wherein the composition undergoes a gel transition at the physiological pH of a breast milk duct, which pH is a range of from about pH 7.5 to about pH 8.2.  
     
     
         27 . A composition as in  claim 26 , wherein the pH is a range of from about pH 7.8 to about pH 8.2.  
     
     
         28 . A composition as in  claim 23 , wherein the polymer is water soluble and comprises a polyethylene polypropylene glycol block copolymer.  
     
     
         29 . A biocompatible composition as in  claim 23 , wherein the therapeutic additive is a chemotherapeutic agent or hormone modulating agent.  
     
     
         30 . A composition of  claim 29 , wherein the therapeutic additive is selected from the group consisting of a tamoxifen, raloxifene, EM 800, droloxifene, ioxdroxifene, RU 39411, RU 58668, ICI 164384, faslodex, soy, a soy isoflavone, a gonadotropin releasing hormone agonist, or an aromatase inhibitor.  
     
     
         31 . A method as in  claim 23 , wherein the gel is selected to have a transition time from the group of transition time ranges consisting of from about 0 to 2 minutes, from about 2 to 5 minutes, from about 6 to 10 minutes, from about 11 to 15 minutes, from about 16 to 20 minutes, from about 21 to 25 minutes, and from about 26 to 30 minutes.  
     
     
         32 . A method as in  claim 23 , wherein the composition is administered using a catheter with a lumen small enough to access a breast milk duct.  
     
     
         33 . A method as in  claim 23 , wherein the lumen of the portion of the catheter that access the breast duct comprises a diameter less than 0.10 inches.  
     
     
         34 . A method of treating a patient at risk for or having a precancer or cancer of a breast duct, said method comprising the following steps: 
 administering to a breast duct through a ductal orifice a composition comprising: a polymer in a solvent capable of a gel transition inside the target duct, wherein the composition is liquid at room temperature and undergoes a gel transition inside the target duct within about 30 minutes of delivery of the composition; and further comprising a therapeutic additive; and    delivering said therapeutic additive in said composition to precancerous or cancerous breast duct tissue and surrounding breast tissue after said composition undergoes a gel transition inside said breast duct;    wherein said therapeutic additive in said biocompatible composition that has undergone a gel transition provides treatment of a precancer or cancer of said breast duct.    
     
     
         35 . A composition of  claim 34 , wherein the polymer is water soluble and comprises a polyethylene polypropylene glycol block copolymer.  
     
     
         36 . A composition of  claim 34 , wherein the solvent is water, wherein the polymer selected from the group consisting of alkyl celluloses, hydroxyalky methyl celluloses, hyaluronic acid, sodium chondroitin sulfate, polyacrylic acid, polyacrylamide, polycyanolacrylates, methyl methacrylate polymers, 2-hydroxyethyl methacrylate polymers, cyclodextrin, polydextrose, dextran, gelatin, polygalacturonic acid, polyvinyl alcohol, polyvinyl pyrrolidone, polyalkylene glycols, and polyethylene oxide, and wherein the composition undergoes a gel transition between about 28° C. and 41° C.  
     
     
         37 . A biocompatible composition as in  claim 34 , wherein the composition undergoes a gel transition at the physiological pH of a breast milk duct, which pH is a range of from about pH 7.5 to about pH 8.2.  
     
     
         38 . A composition as in  claim 37 , wherein the pH is a range of from about pH 7.8 to about pH 8.2.  
     
     
         39 . A composition as in  claim 34 , wherein the polymer is water soluble and comprises a polyethylene polypropylene glycol block copolymer.  
     
     
         40 . A biocompatible composition as in  claim 34 , wherein the therapeutic additive is a chemotherapeutic agent or hormone modulating agent.  
     
     
         41 . A composition of  claim 40 , wherein the therapeutic additive is selected from the group consisting of a tamoxifen, raloxifene, EM 800, droloxifene, ioxdroxifene, RU 39411, RU 58668, ICI 164384, faslodex, soy, a soy isoflavone, a gonadotropin releasing hormone agonist, or an aromatase inhibitor.  
     
     
         42 . A method as in  claim 34 , wherein the gel is selected to have a transition time from the group of transition time ranges consisting of from about 0 to 2 minutes, from about 2 to 5 minutes, from about 6 to 10 minutes, from about 11 to 15 minutes, from about 16 to 20 minutes, from about 21 to 25 minutes, and from about 26 to 30 minutes.  
     
     
         43 . A method as in  claim 34 , wherein the composition is administered using a catheter with a lumen small enough to access a breast milk duct.  
     
     
         44 . A method as in  claim 34 , wherein the lumen of the portion of the catheter that accesses the breast duct comprises a diameter less than 0.10 inches.