Tissue based bioprosthetic heart valve

Abstract

Embodiments herein relate to bioprosthetic heart valves. In an embodiment, a heart valve replacement system is included having a delivery catheter can include a heart valve accommodation region; and a heart valve disposed around the delivery catheter at the heart valve accommodation region of the delivery catheter, the heart valve can include a frame; and a plurality of valve leaflets coupled to the frame; wherein the valve leaflets include an animal tissue, the animal tissue can include from 15% to 50% by weight water; and from 20% to 70% by weight glycerol; a package defining an interior volume, wherein the delivery catheter and the heart valve are disposed within the package. Other embodiments are also included herein.

1 . A heart valve replacement system comprising:
 a delivery catheter comprising a heart valve accommodation region; and   a heart valve disposed around the delivery catheter at the heart valve accommodation region of the delivery catheter, the heart valve comprising
 a frame; and 
 a plurality of valve leaflets coupled to the frame; 
 wherein the valve leaflets comprise 
   an animal tissue, the animal tissue comprising
 from 15% to 50% by weight water; and 
 from 20% to 70% by weight glycerol; 
   a package defining an interior volume, wherein the delivery catheter and the heart valve are disposed within the package.   
     
     
         2 . The heart valve replacement system of  claim 1 , the animal tissue further comprising at least about 0.15% by weight of a cation of a salt, the cation selected from the group consisting of sodium, potassium, calcium and magnesium. 
     
     
         3 . The heart valve replacement system of  claim 1 , further comprising a sheath disposed at least partly over the heart valve, wherein the sheath has an inner diameter of 18 F or smaller. 
     
     
         4 . The heart valve replacement system of  claim 1 , wherein the heart valve is uncrimped onto the delivery catheter and has an outside waist diameter of greater than 20 mm as disposed around the delivery catheter within the package. 
     
     
         5 . The heart valve replacement system of  claim 1 , wherein the heart valve is partially crimped onto the delivery catheter and has an outside waist diameter of from 19 mm to 10 mm as disposed around the delivery catheter within the package. 
     
     
         6 . The heart valve replacement system of  claim 1 , wherein the heart valve is crimped onto the delivery catheter and has an outside waist diameter of less than 7 mm as disposed around the delivery catheter within the package. 
     
     
         7 . The heart valve replacement system of  claim 1 , the animal tissue comprising from 15 to 60% by weight glycerol. 
     
     
         8 . The heart valve replacement system of  claim 1 , the heart valve further comprising
 a skirt, the skirt comprising   an animal tissue, the animal tissue comprising   from 15% to 50% by weight water; and
 from 20% to 70% by weight glycerol. 
   
     
     
         9 . A method of making a heart valve replacement device comprising:
 cutting animal tissue into leaflets;   coupling the leaflets to a frame to form a heart valve;   contacting the leaflets with a composition comprising glycerol;   removing moisture from the leaflets in an environment at above room temperature and/or below atmospheric pressure; and   placing the heart valve on a delivery catheter.   
     
     
         10 . The method of  claim 9 , wherein the composition comprises a glycerol and water mixture. 
     
     
         11 . The method of  claim 9 , wherein the composition comprises a glycerol, water and sodium mixture. 
     
     
         12 . The method of  claim 9 , wherein the composition comprises a glycerol and ethanol mixture. 
     
     
         13 . The method of  claim 9 , wherein the composition comprises a glycerol, water and ethanol mixture. 
     
     
         14 . The method of  claim 9 , further comprising partially crimping the heart valve onto the delivery catheter. 
     
     
         15 . The method of  claim 9 , further comprising fully crimping the heart valve onto the delivery catheter. 
     
     
         16 . The method of  claim 9 , further comprising packaging the heart valve and the delivery catheter, wherein the heart valve remains uncrimped prior to packaging of the heart valve and delivery catheter. 
     
     
         17 . The method of  claim 9 , wherein the operation of contacting the leaflets with a composition comprising glycerol and drying the leaflets is performed before the step of attaching the leaflets to a frame to form a heart valve. 
     
     
         18 . The method of  claim 9 , wherein the leaflets have a water content of about 15 to 50 wt. % and a glycerol content of about 20 to about 70 wt. % after removing moisture. 
     
     
         19 . The method of  claim 9 , further comprising packaging the heart valve and the delivery catheter, wherein the leaflets have a water content of about 15 to about 50 wt. % and a glycerol content of about 20 to about 70 wt. % after being packaged. 
     
     
         20 . The method of  claim 9 , further comprising
 coupling a skirt to the frame;   contacting the skirt with a composition comprising glycerol;   removing moisture from the skirt in an environment at above room temperature and/or below atmospheric pressure.