Method for use of a double-structured tissue implant for treatment of tissue defects
A method for use of a double-structured tissue implant or a secondary scaffold stand-alone implant for treatment of tissue defects. The double-structured tissue implant comprising a primary scaffold and a secondary scaffold consisting of a soluble collagen solution in combination with a non-ionic surfactant generated and positioned within the primary scaffold. A method of use of a stand-alone secondary scaffold implant or unit for treatment of tissue defects.
1. A method for treating a tissue defect comprising:
a. preparing a double-structured tissue implant comprising a three-dimensional primary scaffold;
b. preparing said tissue defect for implantation;
c. precutting said double-structured tissue implant;
d. coating said defect with a tissue adhesive;
e. implanting said double-structured tissue implant into said defect, wherein said implant is rehydrated with a physiologically acceptable solution or buffer before or after implantation; and
f. covering said implant with a tissue adhesive;
wherein said three-dimensional primary scaffold comprises a plurality of pores,
wherein said plurality of pores comprises a secondary scaffold comprising lyophilized and dehydrothermally treated collagen and a surfactant, and
wherein said secondary scaffold forms a fibrous and cross-linked collagen network within said plurality of pores.
2. The method of claim 1 , wherein said primary scaffold defines a top surface and a bottom surface of said implant.
3. The method of claim 1 , wherein the collagen has been lyophilized at a temperature of about −10° C. to about −210° C. over a period of about 2 to about 60 minutes and dehydrothermally treated at a temperature of about 70° C. to about 200° C. for about 30 minutes to about 7 days.
4. The method of claim 1 , wherein the pores have a diameter of about 300±100 μm.
5. The method of claim 4 , wherein the sizes and diameters of the pores on both a top surface of said implant and a bottom surface of said implant are substantially the same.
6. The method of claim 5 , wherein the pores are vertically oriented.
7. The method of claim 1 , wherein the secondary scaffold comprises Type I collagen.
8. The method of claim 1 , wherein the surfactant is a derivatized polyethylene glycol.
9. The method of claim 1 , wherein the implant further comprises a morphogenetic growth factor.
10. The method of claim 1 , wherein the implant further comprises a modulator.
11. The method of claim 1 , wherein the implant further comprises a pharmaceutical agent, a growth factor, a growth hormone, a mediator, an enzyme promoting cell incorporation, an enzyme promoting cell proliferation, an enzyme promoting cell division, a pharmaceutically acceptable excipient, an additive, a buffer, a transforming growth factor, an insulin-like growth factor 1, a platelet-derived growth factor, a repulsive guidance molecule, or a bone morphogenetic protein (BMP).