Biocompatible hydrogel

Abstract

A BIOCOMPATIBLE HYDROGEL, is provided for use in the treatment of humans for cosmetic and functional defects (e.g. in mammas, vocal cords, penis, etc. as endoprostheses), in the provision of intratissue storage sites the prolonged-action medicinal preparations, in various applications as electroconductive immersion media, and in the life-long tamponing of caverns. It contains an acrylamide-based polymer produced in the presence of an initiator of radical polymerization in apyrogenic water as the dispersion medium. An increase in elasticity, shape retention capability, and stability of bulky implants, as well as corresponding therapeutic and cosmetic efficacy, mainly in the endoprosthetic applications is achieved due to the hydrogel containing cross-linked polyacrylamide produced by using a biocompatible cross-linking agent, such as methylene-bis-acrylamide, and preferably a mixture of ammonium persulfate and tetramethylethylenediamine as the initiator of polymerzation. A preferred concentration of the novel polymer in the hydrogel is from 3.5 to 9% by mass.

1. Biocompatible hydrogel for placing endoprostheses by injection, containing cross-linked polyacrylamide produced by radical polymerization and pyrogen-free water, said cross-linked polyacrylamide constituting from 3.5 to 6.0% by weight based on the total weight of the hydrogel. 
     
     
       2. An injectable biocompatible hydrogel prepared from a hydrogel comprising pyrogen- free water and about  3 . 5   %  to about  6   %  polyacrylamide by weight, wherein the resulting biocompatible hydrogel is used for the preparation of a prostheses.   
     
     
       3. A method of treating a cosmetic or functional defect with an injectable biocompatible hydrogel comprising:
   a )  preparing a cross - linked polyacrylamide hydrogel from a solution of about  3 . 5   %  to about  6   %  polyacrylamide by weight;        b )  preparing from the cross - linked polyacrylamide hydrogel a biocompatible hydrogel; and        c )  injecting a sufficient amount of the biocompatible hydrogel into an affected region containing a cosmetic or functional defect.     
     
     
       4. The method of  claim 3 , further comprising:
   d )  repeating treatment steps c sufficient for restoration of the defect.     
     
     
       5. A method of treating a cosmetic or functional defect with an injectable biocompatible hydrogel and creating an endoprosthesis comprising injecting a sufficient amount of biocompatible hydrogel prepared from a cross- linked polyacrylamide hydrogel of about  3 . 5   %  to about  6   %  polyacrylamide by weight into an affected region containing a cosmetic or functional defect, wherein the biocompatible hydrogel serves as an endoprosthesis at the affected site.   
     
     
       6. The method of  claim 5 , wherein the biocompatible hydrogel is prepared from a hydrogel comprising about  3 . 5  to about  6 %  by weight polyacrylamide and pyrogen - free water.   
     
     
       7. The method of  claim 5 , wherein the defect is any one of mammaplasty, phalloplasty, or cosmetic defects. 
     
     
       8. The method of  claim 7 , wherein the defect is aplasia of hypomastia. 
     
     
       9. The method of  claim 5 , wherein the cosmetic defect is a facial defect. 
     
     
       10. The method of  claim 9 , wherein the defect is mandibuloneuromuscular craniofacial microsomia. 
     
     
       11. The method of  claim 5 , wherein the injection is intramuscular. 
     
     
       12. The method of  claim 5 , wherein the injection is subcapsular. 
     
     
       13. The method of  claim 5 , wherein the injection is subfascial. 
     
     
       14. The method of  claim 5 , wherein the injection is intracavernous. 
     
     
       15. The method of  claim 5 , wherein the amount of biocompatible hydrogel injected is from about  1 . 5  ml to about  200  ml. 
     
     
       16. An injectable biocompatible hydrogel prepared from a solution of about  3 . 5 %  to about  6   %  polyacrylamide by weight, wherein the resulting hydrogel is used for the preparation of injectable prostheses.   
     
     
       17. A method of treating a cosmetic or functional defect with an injectable biocompatible hydrogel comprising:
   a )  preparing a cross - linked polyacrylamide solution of about  3 . 5   %  to about  6   %  polyacrylamide by weight for forming a biocompatible hydrogel; and        b )  injecting a sufficient amount of the hydrogel prepared from the cross -linked polyacrylamide solution into an affected region containing a cosmetic or functional defect.   
     
     
       18. The method of  claim 17 , further comprising:
   c )  repeating treatment step b sufficient for restoration of the defect.     
     
     
       19. A method of treating a cosmetic or functional defect with an injectable biocompatible hydrogel and creating an endoprosthesis comprising injecting a sufficient amount of biocompatible hydrogel prepared from a solution of about  3 . 5 %  to about  6   %  polyacrylamide by weight into an affected region containing a cosmetic or functional defect, wherein the hydrogel serves as an endoprosthesis at the affected site.