Gel suitable for implantation and delivery system
View Patent ↗The invention concerns a dried form of a porous polymer gel material which may be rehydrated and placed under pressure or compression to induce salvation, thereby forming a high concentration gel, in the form of an injectable viscous putty or dough, which may be implantated in the body.
1. A process for manufacturing an implantable gel material comprising the steps of:
a. providing a solution comprising a polymeric biomaterial dissolved in a first volume of a first fluid;
b. lyophilizing said first fluid, thereby forming a lyophilized polymeric biomaterial having a large surface area;
c. combining said lyophilized polymeric biomaterial and a rehydrating fluid, wherein said surface area of said lyophilized polymeric biomaterial becomes coated with said rehydrating fluid, and further wherein a second volume of said rehydrating fluid is less than said first volume of said first fluid removed by lyophilization; and
d. solvating said polymeric biomaterial by applying a pressurizing force and no mechanical shearing to said combined rehydrating fluid and lyophilized polymeric biomaterial, whereby said polymeric biomaterial collapses into a gel exhibiting a viscoelastic property.
2. The process of claim 1 , wherein said rehydrating fluid further comprises at least one biologically active agent.
3. The process of claim 1 , wherein said biomaterial further comprises at least one biologically active agent.
4. The process of claim 1 , wherein said biomaterial further comprises at least one filler material.
5. The process of claim 1 , wherein said rehydrating thud further comprises at least one filler material.
6. The process of claim 1 , wherein both fluids comprise water.
7. The process of claim 1 , wherein at least one fluid comprises saline.
8. The process of claim 1 , wherein said polymeric biomaterial is selected from the group consisting of soluble collagen and PLA.
9. The process of claim 4 , wherein said filler material comprises at least one member selected from the group consisting of hydroxylapatite and fibrous collagen.
10. The process of claim 1 , wherein said implantable gel material further comprises at least one biologically active agent.
11. A process for manufacturing an implantable gel material comprising the steps of:
a. providing a solution comprising a polymeric biomaterial dissolved in a first fluid;
b. lyophilizing said first fluid to form a lyophilized polymeric biomaterial;
c. combining said lyophilized polymeric biomaterial and a rehydrating fluid, wherein said surface area of said lyophilized polymeric biomaterial becomes coated with said rehydrating fluid; and
d. solvating said polymeric biomaterial by applying a pressurizing force and no mechanical shearing to said combined rehydrating fluid and polymeric biomaterial, whereby said polymeric biomaterial collapses into a viscous gel.
12. The process of claim 11 , wherein a volume of said rehydrating fluid is less than a volume of said first fluid removed during lyophilization.
13. The process of claim 11 , wherein said pressurizing force consists essentially of a compressive force.