Tissue based bioprosthetic heart valve
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 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;
wherein coupling the leaflets to the frame occurs prior to removing moisture from the leaflets in the environment at above room temperature and/or below atmospheric pressure;
wherein the leaflets of the heart valve are glutaraldehyde-free when placed on the delivery catheter.
2 . The method of claim 1 , wherein the composition comprises at least 50% glycerol by weight.
3 . The method of claim 2 , wherein the composition comprises no more than 98% glycerol by weight.
4 . The method of claim 3 , wherein the composition comprises at least 70% glycerol by weight.
5 . The method of claim 4 , wherein the composition comprises at least 90% glycerol by weight.
6 . The method of claim 2 , wherein the composition comprises glycerol and water.
7 . The method of claim 6 , wherein the composition further comprises sodium.
8 . The method of claim 2 , further comprising at least partially crimping the heart valve onto the delivery catheter.
9 . The method of claim 8 , further comprising packaging the heart valve and the delivery catheter into a package.
10 . The method of claim 1 , 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.
11 . The method of claim 1 , further comprising
coupling an inner skirt to the frame;
contacting the inner skirt with a composition comprising glycerol;
removing moisture from the inner skirt in an environment at above room temperature and/or below atmospheric pressure.
12 . The method of claim 11 , further comprising
coupling an outer skirt to the frame;
contacting the outer skirt with a composition comprising glycerol;
removing moisture from the outer skirt in an environment at above room temperature and/or below atmospheric pressure.
13 . The method of claim 1 , further comprising
disposing a sheath over the heart valve and at least a portion of the delivery catheter.
14 . The method of claim 13 , wherein an outside waist diameter of the sheath is less than 15 mm.
15 . The method of claim 14 , wherein the sheath has an inner diameter of 18 F or smaller.
16 . The method of claim 13 , further comprising packaging the heart valve, sheath, and the delivery catheter into a package.
17 . The method of claim 1 , wherein the delivery catheter comprises a balloon.
18 . The method of claim 17 , wherein the delivery catheter defines an inflation lumen.
19 . The method of claim 17 , wherein the balloon is distal relative to the heart valve.
20 . The method of claim 1 , wherein the heart valve is an aortic heart valve.