Supercritical method of making a biocompatible composite implant
Disclosed herein is biocompatible composite material impregnated with antiinfective agents to reduce the rate of infection in patients with medical implants. Also disclosed herein is the utilization of super critical fluid (SCF) methodology to impregnate medical implant materials with antiinfective agents (e.g., antimicrobial, antibiofilm agents, etc.).
1. A method of preparing a medical implant composition, comprising:
(i) placing the base material in an enclosure, wherein the base material comprises a surface portion and an interior portion;
(ii) allowing supercritical fluid carbon dioxide (SCF—CO 2 ) to flow into the enclosure and contact the base material in the presence of a bioprotectant at an elevated pressure; and
(iii) reducing pressure in the enclosure after at least 30% of the interior portion of the base material is impregnated with the bioprotectant,
wherein the base material is polypropylene or decellularized tissue.
2. The method of claim 1 , wherein the base material and bioprotectant are placed in the enclosure before SCF—CO 2 enters the enclosure.
3. The method of claim 1 , wherein the bioprotectant is combined with SCF—CO 2 to form a mixture before the mixture contacts the base material in the enclosure.
4. The method of claim 1 wherein the elevated pressure is from about 500 psi to about 6000 psi.
5. The composition of claim 4 , wherein the elevated pressure is from about 500 psi to about 2500 psi.
6. The method of claim 5 , wherein temperature in the enclosure is from about 15° C. to about 60° C. during the contact.
7. The method of claim 6 , wherein base material comprises decellularized tissue.
8. The method of claim 4 , wherein the elevated pressure is from about 2500 psi to about 6000 psi.
9. The method of claim 8 , wherein temperature in the enclosure is from about 60° C. to about 160° C.
10. The method of claim 9 , wherein base material comprises polypropylene.
11. The method of claim 1 , wherein the contact of the base material and the bioprotectant with SCF—CO 2 occurs for a period of from about 1 minute to about 24 hours.
12. The method of claim 1 , wherein the contact of the base material and the bioprotectant with SCF—CO 2 occurs for a period of from about 5 minutes to about 8 hours.
13. The method of claim 1 , wherein the contact of SCF—CO 2 with the base material occurs in the presence of the bioprotectant and a solvent.
14. The method of claim 13 , wherein the solvent is combined with bioprotectant prior to the contact of SCF—CO 2 with the base material.
15. The method of claim 13 , wherein the solvent is combined with SCF—CO 2 prior to the contact of SCF—CO 2 with the base material in the presence of the bioprotectant.
16. The method of claim 1 , wherein the base material is a surgical mesh material.
17. The method of claim 1 , wherein the base material is decellularized bone tissue.
18. The method of claim 1 , wherein the bioprotectant is an immunosuppressant agent or an anti-infective agent.
19. The method of claim 18 , wherein the anti-infective agent is an anti-microbial agent, an anti-biofilm agent, or a combination thereof.
20. The method of claim 18 , wherein the anti-infective agent is a quaternary ammonium salt.
21. The method of claim 20 , wherein the quaternary ammonium salt comprises C12 or C14 alkyl chain.
22. The method of claim 20 , wherein the quaternary ammonium salt is C12-C14-alkyl(ethylbenzyl)dimethylammonium chloride.
23. The method of claim 18 , wherein the immunosuppressant agent is a calcineurin inhibitors.
24. The method of claim 18 , wherein the immunosuppressant agent is selected from the group consisting of cyclosporine, tacrolimus, and pimecrolimus.
25. The method of claim 18 , wherein the immunosuppressant agent is tacrolimus.
26. The method of claim 1 , wherein the bioprotectant is impregnated throughout the medical implant material.
27. The method of claim 1 , wherein at least 50% of the interior portion of the base material is impregnated with the bioprotectant.
28. The method of claim 1 , wherein at least 60% of the interior portion of the base material is impregnated with the bioprotectant.
29. The method of claim 1 , wherein at least 70% of the interior portion of the base material is impregnated with the bioprotectant.