Tissue forms derived from membranous tissue

Abstract

The present invention relates generally to tissue forms useful as grafts or implants and derived from membranous tissue. The tissue forms may contain viable endogenous cells. The tissue forms may be sheets or mini sheets, each having quadrilateral, circular, polygonal, or irregular shapes. The sheet tissue form may have a generally quadrilateral shape, with an average length of about 1 to about 20 centimeters and an average width of about 1 to about 20 centimeters. The mini sheet tissue form may have a generally quadrilateral shape, with an average length of about 0.5 to about 9 millimeters and an average width of about 0.5 to about 9 millimeters. A mixture of the mini sheet tissue form and a liquid, such as cryopreservation fluid, saline or buffer solution, is flowable, which means the mixture will pass through a luer-slip tip syringe, or a gauge needle.

1 . A method for producing a tissue graft comprising at least one processed tissue fragment derived from naturally occurring unprocessed membranous tissue, the method comprising:
 obtaining the unprocessed membranous tissue comprising amnion membrane which has an unprocessed population size of endogenous cells; and   subjecting the unprocessed membranous tissue to one or more processes selected from:   a cleaning process, a soaking process, a bioburden reducing process, an additional soaking process, a rinsing process, and a freezing process,   wherein at least one or more of the processes is performed by contacting the unprocessed membraneous tissue with one or more solutions,   wherein none of the solutions comprises an anticoagulant,   thereby producing the at least one processed tissue fragment, which has a retained population size of endogenous cells which is at least 90 percent of the unprocessed population size, and at least 70 percent of the retained population size of endogenous cells are viable.   
     
     
         2 . The method for producing a tissue graft of  claim 1 , wherein at least one of the one or more solutions comprises one or more monosaccharides. 
     
     
         3 . The method for producing a tissue graft of  claim 2 , wherein the one or more monosaccharides comprises at least one of: glucose, fructose, and galactose. 
     
     
         4 . The method for producing a tissue graft of  claim 1 , wherein the bioburden reducing process comprises contacting the unprocessed membraneous tissue with an antibiotic solution for a short period of time which is less than about 60 minutes. 
     
     
         5 . The method for producing a tissue graft of  claim 4 , wherein at least one of the one or more solutions comprises one or more monosaccharides. 
     
     
         6 . The method for producing a tissue graft of  claim 4 , wherein the freezing process comprises a controlled rate freezing process. 
     
     
         7 . The method for producing a tissue graft of  claim 6 , wherein at least one of the one or more solutions comprises one or more monosaccharides. 
     
     
         8 . The method for producing a tissue graft of  claim 1 , wherein the freezing process comprises a controlled rate freezing process. 
     
     
         9 . The method for producing a tissue graft of  claim 8 , wherein at least one of the one or more solutions comprises one or more monosaccharides. 
     
     
         10 . The method for producing a tissue graft of  claim 1 , wherein the freezing process comprises contacting the unprocessed membranous tissue with a cryopreservation solution which lacks serum. 
     
     
         11 . The method for producing a tissue graft of  claim 10 , wherein at least one of the one or more solutions comprises one or more monosaccharides. 
     
     
         12 . The method for producing a tissue graft of  claim 10 , wherein the freezing process comprises a controlled rate freezing process. 
     
     
         13 . The method for producing a tissue graft of  claim 12 , wherein at least one of the one or more solutions comprises one or more monosaccharides. 
     
     
         14 . The method for producing a tissue graft of  claim 1 , wherein the at least one processed tissue fragment comprises either:
 at least one sheet, each having a shape with an average length of about 1 to about 20 centimeters (cm) and an average width of about 1 to about 20 cm, or   at least one mini sheet, each having a shape with an average length of about 0.5 to about 9 mm and an average width of about 0.5 to about 9 mm.   
     
     
         15 . The method for producing a tissue graft of  claim 14 , wherein the at least one processed tissue fragment comprises at least one sheet, each having a shape with an average length of about 1 to about 10 centimeters (cm) and an average width of about 1 to about 10 cm. 
     
     
         16 . A method for producing a tissue graft comprising at least one processed tissue fragment derived from naturally occurring unprocessed membranous tissue, the method comprising:
 obtaining the unprocessed membranous tissue comprising amnion membrane which has an unprocessed population size of endogenous cells; and   subjecting the unprocessed membranous tissue to one or more processes selected from:   a cleaning process, a soaking process, a bioburden reducing process, an additional soaking process, a rinsing process, and a freezing process,   wherein at least one or more of the processes is performed by contacting the unprocessed membraneous tissue with one or more solutions,   wherein the bioburden reducing process comprises contacting the unprocessed membraneous tissue with an antibiotic solution for a short period of time which is less than about 60 minutes,   thereby producing the at least one processed tissue fragment, which has a retained population size of endogenous cells which is at least 90 percent of the unprocessed population size, and at least 70 percent of the retained population size of endogenous cells are viable.   
     
     
         17 . The method for producing a tissue graft of  claim 16 , wherein the short period of time is less than about 30 minutes. 
     
     
         18 . The method for producing a tissue graft of  claim 16 , wherein the short period of time is less than about 10 minutes. 
     
     
         19 . The method for producing a tissue graft of  claim 16 , wherein the short period of time is from about 1 minute to less than about 5 minutes. 
     
     
         20 . The method for producing a tissue graft of  claim 16 , wherein at least one of the one or more solutions comprises one or more monosaccharides. 
     
     
         21 . The method for producing a tissue graft of  claim 20 , wherein the one or more monosaccharides comprises at least one of: glucose, fructose, and galactose. 
     
     
         22 . The method for producing a tissue graft of  claim 16 , wherein the freezing process comprises a controlled rate freezing process. 
     
     
         23 . The method for producing a tissue graft of  claim 22 , wherein at least one of the one or more solutions comprises one or more monosaccharides. 
     
     
         24 . The method for producing a tissue graft of  claim 16 , wherein the freezing process comprises contacting the unprocessed membranous tissue with a cryopreservation solution which lacks serum. 
     
     
         25 . The method for producing a tissue graft of  claim 24  wherein at least one of the one or more solutions comprises one or more monosaccharides. 
     
     
         26 . The method for producing a tissue graft of  claim 24 , wherein the freezing process comprises a controlled rate freezing process. 
     
     
         27 . The method for producing a tissue graft of  claim 26 , wherein at least one of the one or more solutions comprises one or more monosaccharides. 
     
     
         28 . The method for producing a tissue graft of  claim 16 , wherein the at least one processed tissue fragment comprises either:
 at least one sheet, each having a shape with an average length of about 1 to about 20 centimeters (cm) and an average width of about 1 to about 20 cm, or   at least one mini sheet, each having a shape with an average length of about 0.5 to about 9 mm and an average width of about 0.5 to about 9 mm.   
     
     
         29 . The method for producing a tissue graft of  claim 28 , wherein the at least one processed tissue fragment comprises at least one sheet, each having a shape with an average length of about 1 to about 10 centimeters (cm) and an average width of about 1 to about 10 cm. 
     
     
         30 . A method for producing a tissue graft comprising at least one processed tissue fragment derived from naturally occurring unprocessed membranous tissue, the method comprising:
 obtaining the unprocessed membranous tissue comprising amnion membrane which has an unprocessed population size of endogenous cells;   subjecting the unprocessed membranous tissue to one or more processes selected from:   a cleaning process, a soaking process, a bioburden reducing process, an additional soaking process, a rinsing process, and a freezing process,   wherein at least one or more of the processes is performed by contacting the unprocessed membraneous tissue with one or more solutions,   wherein the freezing process comprises contacting the unprocessed membranous tissue with a cryopreservation solution which lacks serum,   thereby producing the at least one processed tissue fragment, which has a retained population size of endogenous cells which is at least 90 percent of the unprocessed population size, and at least 70 percent of the retained population size of endogenous cells are viable.   
     
     
         31 . The method for producing a tissue graft of  claim 30 , wherein at least one of the one or more solutions comprises one or more monosaccharides. 
     
     
         32 . The method for producing a tissue graft of  claim 31 , wherein the one or more monosaccharides comprises at least one of: glucose, fructose, and galactose. 
     
     
         33 . The method for producing a tissue graft of  claim 30 , wherein the freezing process comprises a controlled rate freezing process. 
     
     
         34 . The method for producing a tissue graft of  claim 33 , wherein at least one of the one or more solutions comprises one or more monosaccharides. 
     
     
         35 . The method for producing a tissue graft of  claim 30 , wherein the at least one processed tissue fragment comprises either:
 at least one sheet, each having a shape with an average length of about 1 to about 20 centimeters (cm) and an average width of about 1 to about 20 cm, or   at least one mini sheet, each having a shape with an average length of about 0.5 to about 9 mm and an average width of about 0.5 to about 9 mm.   
     
     
         36 . The method for producing a tissue graft of  claim 35 , wherein the at least one processed tissue fragment comprises at least one sheet, each having a shape with an average length of about 1 to about 10 centimeters (cm) and an average width of about 1 to about 10 cm. 
     
     
         37 . A method for producing a tissue graft comprising at least one processed tissue fragment derived from naturally occurring unprocessed membranous tissue, the method comprising:
 obtaining the unprocessed membranous tissue comprising amnion membrane which has an unprocessed population size of endogenous cells and a bioburden;   cleaning the unprocessed membranous tissue by manually manipulating the unprocessed membranous tissue to at least remove blood clots;   performing a first soak by contacting the unprocessed membranous tissue with a first isotonic salt solution for a first period of time of from about 10 to about 20 minutes,   optionally performing a second soak by draining the isotonic salt solution from the membranous tissue and contacting the membranous tissue with a second isotonic salt solution for a second period of time of from about 10 to about 20 minutes;   reducing the bioburden of the membranous tissue by contacting the membranous tissue with an antibiotic solution comprising an antibiotic for a period of time of at least about 30 minutes and less than about 60 minutes;   performing one or more additional soaks, after reducing the bioburden, to rinse the antibiotic solution away from the membranous tissue by contacting the membranous tissue at least once with a third isotonic salt solution for at least a third period of time of from about 5 to about 10 minutes and contacting the membranous tissue with a fourth isotonic salt solution for at least a fourth period of time of from about 30 to about 40 minutes, thereby producing a processed membranous tissue;   producing the at least one processed membranous tissue fragment by mechanically cutting the membranous tissue with a device having one or more blades;   optionally placing the at least one processed membranous tissue fragment into a packaging and filling the packaging with cryopreservation solution, wherein no serum is included in the cryopreservation solution; and   optionally freezing the at least one processed membranous tissue fragment by controlled rate freezing to −80° C. or less, wherein the freezing step is initiated within about 8 hours after completion of the cleaning step and within about 1 hour after the filling with cryopreservation solution step is performed;   wherein each of the first, second, third, and fourth isotonic salt solutions is, independently, the same or different from the other isotonic salt solutions;   wherein no anticoagulant is included in any of the first, second, third, or fourth isotonic salt solutions, the antibiotic solution, or the cryopreservation solution; and   wherein one or more of the buffer and antibiotic solutions comprises a monosaccharide comprising glucose,   such that the at least one processed tissue fragment has a retained population size of endogenous cells which is at least 90 percent of the unprocessed population size, and at least 70 percent of the retained population size of endogenous cells are viable.