Double-structured tissue implant and a method for preparation and use thereof
View Patent ↗A double-structured tissue implant and a method for preparation and use thereof for implantation into tissue defects. The double-structured tissue implant comprising a primary scaffold comprised of collagen and a secondary scaffold comprising a soluble collagen solution in combination with a surfactant generated and positioned within the primary scaffold. A process for preparation of the double-structured implant or the stand alone secondary scaffold comprising lyophilization and dehydrothermal treatment.
1. A method of making a double-structured tissue implant, the method comprising:
obtaining a primary scaffold comprising collagen, the primary scaffold comprising a porous structure having a plurality of pores;
preparing a composition comprising a second collagen and a surfactant;
introducing the composition into the plurality of pores of the primary scaffold; and
stabilizing the composition within the plurality of pores of the primary scaffold, thereby producing a double-structured tissue implant, wherein the stabilizing step comprises precipitation, dehydration, and lyophilization.
2. The method of claim 1 , wherein the primary scaffold comprises Type I collagen.
3. The method of claim 2 , wherein the second collagen comprises Type I or Type II collagen.
4. The method of claim 2 , wherein the surfactant is a non-ionic surfactant.
5. The method of claim 4 , wherein the non-ionic surfactant is a polymeric compound.
6. The method of claim 2 , wherein the surfactant is an ionic surfactant.
7. The method of claim 2 , wherein the composition is soluble in water.
8. The method of claim 2 , wherein the composition comprises cells.
9. The method of claim 2 , wherein the composition comprises at least one pharmaceutical agent.
10. The method of claim 9 , wherein the pharmaceutical agent is a drug.
11. The method of claim 2 , wherein the composition comprises a growth modulator.
12. The method of claim 1 , wherein the stabilizing step comprises cross-linking the composition within the pores of the primary scaffold with short wave length ultraviolet irradiation at 254 nm.
13. The method of claim 2 , further comprising subjecting the double-structured tissue implant to a dehydrothermal treatment.
14. The method of claim 13 , wherein the dehydrothermal treatment comprises subjecting the double-structured tissue implant to temperatures in a range from about 70 degrees C. to about 200 degrees C. under vacuum for about 30 minutes to about 7 days.
15. The method of claim 13 , wherein the dehydrothermal treatment comprises subjecting the double-structured tissue implant to temperatures from about 130 degrees C. to about 150 degrees C. under vacuum for about 5-7 hours.