Double-structured tissue implant and a method for preparation and use thereof

Abstract

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 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 stand alone secondary scaffold implant or unit. A process for preparation of the double-structured implant or the stand alone secondary scaffold comprising lyophilization and dehydrothermal treatment.

1 - 20 . (canceled) 
     
     
         21 . A tissue implant comprising:
 a primary scaffold comprising a first collagen and a plurality of pores; and   a secondary scaffold comprising a second collagen, the secondary scaffold forming a fibrous and cross-linked collagen network within the plurality of pores.   
     
     
         22 . The tissue implant of  claim 21 , wherein the secondary scaffold is a collagenous solution or gel comprising the second collagen and a surfactant. 
     
     
         23 . The tissue implant of  claim 22 , wherein the collagenous solution or gel is lyophilized within the plurality of pores. 
     
     
         24 . The tissue implant of  claim 22 , the surfactant is a non-ionic surfactant. 
     
     
         25 . The tissue implant of  claim 24 , wherein the non-ionic surfactant is a polymeric compound. 
     
     
         26 . The tissue implant of  claim 21 , wherein the first collagen comprises Type I collagen. 
     
     
         27 . The tissue implant of  claim 26 , wherein the second collagen comprises Type I collagen. 
     
     
         28 . The tissue implant of  claim 21 , wherein the second collagen comprises Type I collagen. 
     
     
         29 . The tissue implant of  claim 21 , wherein the secondary scaffold comprises cells. 
     
     
         30 . The tissue implant of  claim 21 , wherein the plurality of pores have a substantially homogeneous defined diameter. 
     
     
         31 . The tissue implant of  claim 21 , wherein the primary scaffold has a substantially defined pore size in diameter and pore density that creates a top surface and a bottom surface to the tissue implant wherein the size and diameters of the pores on both the top and bottom surface are substantially the same. 
     
     
         32 . The tissue implant of  claim 31 , wherein the pores are oriented substantially vertically having a pore size of about 200 plus/minus 100 micrometer. 
     
     
         33 . The tissue implant of  claim 21 , further comprising a top surface and a bottom surface, wherein the plurality of pores are vertically oriented and have a pore diameter of about 300 plus/minus 100 micrometer at the top surface and the bottom surface. 
     
     
         34 . The tissue implant of  claim 33 , wherein the secondary scaffold comprises Type I collagen as the second collagen and further comprises a non-ionic surfactant. 
     
     
         35 . The tissue implant of  claim 34 , wherein the tissue implant has dimensions of about 50 mm and a vertical thickness between about 1 and 5 mm. 
     
     
         36 . The tissue implant of  claim 21 , wherein the primary scaffold has a honeycomb structure. 
     
     
         37 . The tissue implant of  claim 21 , wherein the secondary scaffold is a basic collagenous solution. 
     
     
         38 . The tissue implant of  claim 21 , wherein fibrous and cross-linked collagen network comprises collagen fibers that interdigitate within the and among the plurality of pores. 
     
     
         39 . The tissue implant of  claim 21 , wherein the plurality of pores have a pore size of about 200 plus/minus 100 micrometer 
     
     
         40 . The tissue implant of  claim 21 , further comprising one selected from the group consisting of: a growth factor, a morphogenic factor, a cytokine, a membrane associated factor, a cell attachment protein, an adhesion protein, a hormone, a pericellular matrix molecule, a nutrient, a nucleic acid, an anti-neoplastic agent, a vitamin, an anti-inflammatory agent, an enzyme, a metabolic inhibitor.