Polyacrylamide hydrogel as a soft tissue filler endoprosthesis
A hydrogel is obtained by combining acrylamide and methylene bis-acrylamide, radical initiation and washing with pyrogen-free water or saline solution to give less than 3.5% by weight polyacrylamide, based on the total weight of the hydrogel. The hydrogel may be used as a soft tissue filler endoprosthesis. Also disclosed is a method of filling a soft tissue in a mammal using the endoprosthesis, and a prosthetic device comprising the polyacrylamide hydrogel.
1. A method of filling soft tissue comprising administering a hydrogel as an endoprosthesis to an area in need thereof,
said hydrogel comprising about 0.5 to less than 3.5% by weight polyacrylamide, based on the total weight of the hydrogel; wherein the polyacrylamide is crosslinked polyacrylamide;
said hydrogel consisting essentially of a polymer of said crosslinked polyacrylamide,
and at least 95% by weight pyrogen-free water or saline solution, and
less than 50 ppm of acrylamide and methylene-bis-acrylamide monomers,
and wherein the hydrogel has an elasticity module from about 10 to 700 Pa and a complex viscosity from about 2 to 100 Pas,
and wherein said endoprosthesis consists essentially of said hydrogel.
2. The method according to claim 1 , wherein the endoprosthesis does not comprise an antibiotic, analgesic or anti-inflammatory agent.
3. The method according to claim 1 , wherein the hydrogel is obtainable by combining acrylamide and methylene bis-acrylainide in a molar ratio of 150:1 to 1000:1.
4. The method according to claim 1 , wherein the hydrogel comprises at least 1.0% by weight polyacrylamide, based on the total weight of the hydrogel.
5. The method according to claim 1 , wherein the hydrogel comprises from about 2.0 to 3.0% by weight polyacrylamide, based on the total weight of the hydrogel.
6. The method according to claim 1 , wherein the soft tissue is soft tissue of the face; wherein the endoprosthesis is for facial cosmetic or reconstructive surgery; and wherein the hydrogel has a complex viscosity of about 2 to 20 Pas.
7. The method according to claim 1 , wherein the soft tissue is soft tissue of the body; wherein the endoprosthesis is for cosmetic or reconstructive surgery of the body (body contouring), and wherein the hydrogel has a complex viscosity of about 5 to 50 Pas.
8. The method according to claim 1 , wherein the soft tissue is soft tissue of the lip; wherein the endoprosthesis is for lip augmentation or lip reconstruction; and wherein said hydrogel has a complex viscosity of about 2 to 10 Pas.
9. The method according to claim 1 , wherein the administering comprises injecting the hydrogel.
10. The method according to claim 9 , wherein the endoprosthesis is for facial cosmetic or reconstructive surgery or body contouring and the injecting is into the subcutaneous layer of the skin.
11. The method according to claim 9 , wherein the endoprosthesis is for lip augmentation or lip reconstruction and the injecting is above the muscle tissue of the lip.
12. The method according to claim 9 , further comprising administering cells for cellular engrafment to the surrounding tissue.
13. The method according to claim 1 , wherein the hydrogel comprises at least 1.5% and less than 3.5% by weight polyacrylamide, based on the total weight of the hydrogel.
14. The method according to claim 1 , wherein the soft tissue is soft tissue of the face; wherein the endoprosthesis is for facial cosmetic or reconstructive surgery; and wherein the hydrogel has a complex viscosity of about 2 to 18 Pas.
15. The method according to claim 1 , wherein the soft tissue is soft tissue of the face; wherein the endoprosthesis is for facial cosmetic or reconstructive surgery; and wherein the hydrogel has a complex viscosity of about 2 to 15 Pas.
16. The method according to claim 1 , wherein the soft tissue is soft tissue of the face; wherein the endoprosthesis is for facial cosmetic or reconstructive surgery; and wherein the hydrogel has a complex viscosity of about 2 to 10 Pas.
17. The method according to claim 1 , wherein the soft tissue is soft tissue of the face; wherein the endoprosthesis is for facial cosmetic or reconstructive surgery; and wherein the hydrogel has a complex viscosity of about 2 to 7 Pas.
18. The method according to claim 1 , wherein the soft tissue is soft tissue of the face; wherein the endoprosthesis is for facial cosmetic or reconstructive surgery; and wherein the hydrogel has a complex viscosity of about 3 to 5 Pas.
19. The method according to claim 1 , wherein the soft tissue is soft tissue of the body; wherein the endoprosthesis is for cosmetic or reconstructive surgery of the body (body contouring), and wherein the hydrogel has a complex viscosity of about 7 to 40 Pas.
20. The method according to claim 1 , wherein the soft tissue is soft tissue of the body; wherein the endoprosthesis is for cosmetic or reconstructive surgery of the body (body contouring), and wherein the hydrogel has a complex viscosity of about 7 to 30 Pas.
21. The method according to claim 1 , wherein the soft tissue is soft tissue of the lip; wherein the endoprosthesis is for lip augmentation or lip reconstruction; and wherein said hydrogel has a complex viscosity of about 2 to 7 Pas.
22. The method according to claim 1 , wherein the soft tissue is soft tissue of the lip; wherein the endoprosthesis is for lip augmentation or lip reconstruction; and wherein said hydrogel has a complex viscosity of about 3 to 5 Pas.
23. The method according to claim 12 , wherein the cells are stem cells.
24. The method according to claim 1 , wherein the hydrogel has an elasticity module of not less than 25 Pa.
25. The method according to claim 1 , wherein the hydrogel has an elasticity module of not less than 38 Pa.
26. The method according to claim 1 , wherein the hydrogel has an elasticity module of about 35 to 480 Pa.