FORMULATIONS CONTAINING POLY (0-2 HYDROXYETHYL) STARCH FOR INCREASING THE OXYGEN-CONTENT, STABILITY AND SHELF LIFE OF AN ORGAN AND TISSUE PRESERVATION SOLUTION
Organ and tissue preservation solutions having improved formulations. The improved solutions are comprised of two separate solutions. The first solution, is comprised of one or more salts, water, dissolved oxygen, Poly (0-2-hydroxyethyl) starch, lactobionic acid, adenosine, raffinose and allopurinol and said first solution has a pH of at least 7.0;, preferably from about 7.3 to about 8.2; and a second solution comprised of water, and reduce glutathione at a pH of below 7.0, preferably from about 3 to 6 wherein oxygen present in the solution is removed. The two formulations are then mixed together at the point of use resulting in the organ and tissue preservation solution having improved stability and that contains oxygen to prevent ischemia in the preserved organs. The present invention is also comprised of kits that contain the two formulations.
1 . An organ and preservation kit comprised of a first aqueous solution contained in a first container and a second solution contained in a second container wherein the first aqueous solution is comprised of a one or more salts, water, dissolved oxygen, Poly (0-2-hydroxyethyl) starch, and at least one of lactobionic acid, adenosine, raffinose and allopurinol and said first solution has a pH of at least 7.0; wherein the second solution is comprised of water, reduced glutathione and said second solution has a pH of below 7 and the second solution contains substantially no oxygen.
2 . The kit of claim 1 wherein the first and second containers are first and second chambers of a single container and the first and second chambers are separated by a removable partition, wherein upon the removal of the partition, the first solution mixes with the second solution to form the complete organ and tissue preservation solution.
3 . The kit of claim 1 wherein the pH of the first solution is about from about 7.3 to about 8.2 and the pH of the second solution is from about 3 to about 6.
4 . A method for preparing an organ or tissue preservation solution comprising;
combining a first solution comprising mixing water, one or more salts Poly (0-2-hydroxyethyl) starch, and at least one of lactobionic acid, adenosine, raffinose and allopurinol wherein the first solution contains dissolved oxygen and has a pH of above 7;
with a second solution comprising mixing water and glutathione together at a pH of below 7 and removing oxygen from the second solution; and at the point of use.
5 . The process of claim 4 wherein the pH of the first solution is from about 7.3 to 8.3 and the pH of the second solution is from about 3 to 6.
6 . A method for preserving a tissue or organ comprised of bringing the tissue or organ into contact with a solution made according to the process of claim 4 .
7 . The method of claim 7 wherein the tissue or organ is selected from the group consisting of saphenous veins, epigastric arteries, gastroepiploic arteries, radial arteries, heart, lungs, kidney, brain, muscle grafts, skin, intestine, bone, appendages, eyes, and portions of said tissue or organs.
8 . An organ and preservation kit comprised of a first aqueous solution contained in a first container and a second solution contained in a second container wherein the first aqueous solution is comprised of a one or more salts, water, dissolved oxygen, and a hydroxyethyl starch, and said first solution has a pH of at least 7.0; and wherein the second solution is comprised of water and reduced glutathione and said second solution has a pH of below 7 and the second solution contains substantially no oxygen.
9 . The organ and preservation kit of claim 8 wherein the hydroxyethyl starch is a Poly (0-2-hydroxyethyl) starch.