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.

What is claimed is:  
     
         1 . 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 kilodaltons and a weight/weight ratio of polymer to solvent in a range between about 0.5:100 to 100:0.5, wherein the composition is liquid in a solvent and undergoes a gel transition inside a target breast milk duct within about 30 minutes of delivery of the composition to the target duct, wherein the gel transition occurs as a result of in situ cross linking of the gel composition, and wherein the gel composition comprises cross linkable free radicals, or cationic/anionic cross linkable moieties.  
     
     
         2 . A composition as in  claim 1 , wherein the polymer is water soluble and comprises a polyethylenepolypropylene glycol block copolymer.  
     
     
         3 . 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 kilodaltons and a weight/weight ratio of polymer to solvent in a range between about 0.5:100 to 100:0.5, wherein the composition is liquid in a solvent and undergoes a gel transition inside a target breast milk duct within about 30 minutes of delivery of the composition to the target duct, wherein the gel transition occurs as a result of in situ cross linking of the gel composition, and wherein the cross linking reaction is activated by a process selected from the group consisting of a chemical reaction, a change in temperature, and application of energy.  
     
     
         4 . A composition as in  claim 3  wherein the cross linking is activated by an application of energy and the energy source is selected from the group consisting of radiation, magnetic, ultrasonic, ultra-violet, radio frequency, visible light, and heat.  
     
     
         5 . A biocompatible composition as in  claim 3 , wherein the solvent is water, wherein the polymer is 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° and 41° C.  
     
     
         6 . A biocompatible composition as in  claim 3 , 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.  
     
     
         7 . A composition as in  claim 6 , wherein the pH is in a range from about pH 7.8 to about pH 8.2.  
     
     
         8 . A composition as in  claim 3 , wherein the polymer is water soluble and comprises a polyethylenepolypropylene glycol block copolymer.  
     
     
         9 . A biocompatible composition as in  claim 3 , the composition further comprising a therapeutic additive.  
     
     
         10 . 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 kilodaltons and a weight/weight ratio of polymer to solvent in a range between about 0.5:100 to 100:0.5, wherein the composition is liquid in a solvent and undergoes a gel transition inside a target breast milk duct within about 30 minutes of delivery of the composition to the target duct, further comprising an additive to provide detection of the gel inside the target duct, which additive is selected from the group consisting of a dye capable of staining ductal tissue with a color visible to the naked eye, a fluorescent dye, a radiograph contrast agent, a radionuclide, a ferromagnetic material, a sonographically reflective material, a thermographically reflective material, an impedance altering molecule, a radioactive agent, a vital dye, and an agent detectable by infrared sensor.  
     
     
         11 . A composition as in  claim 10 , wherein the additive is a dye and the dye is a food coloring dye.  
     
     
         12 . A composition as in  claim 10 , wherein the additive is a dye and the dye is selected from the group consisting of isosulfan blue, methylene blue, Chicago sky blue, marina blue, tetramethylrhodamine, Texas red-X, and Oregon green.  
     
     
         13 . A composition as in  claim 10 , wherein the dye is a fluorescent dye and the fluorescent dye is selected from the group consisting of fluorescein, rhodamine and, indocyanine green.  
     
     
         14 . 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 kilodaltons and a weight/weight ratio of polymer to solvent in a range between about 0.5:100 to 100:0.5, wherein the composition is liquid in a solvent and undergoes a gel transition inside a target breast milk duct within about 30 minutes of delivery of the composition to the target duct, the composition farther comprising an additive to provide detection of the gel before incision through the breast tissue and skin, wherein the additive is a dye.  
     
     
         15 . 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 kilodaltons and a weight/weight ratio of polymer to solvent in a range between about 0.5:100 to 100:0.5, wherein the composition is liquid in a solvent and undergoes a gel transition inside a target breast milk duct within about 30 minutes of delivery of the composition to the target duct, further comprising a diagnostic additive.