Compositions, methods and devices for maintaining an organ
View Patent ↗Compositions, methods, systems/devices and media are provided for maintaining a harvested organ in a functioning and viable state prior to implantation. The organ perfusion apparatus includes a preservation chamber for storing the organ during the preservation period. A perfusion circuit is provided having a first line for providing an oxygenated fluid to the organ, and a second line for carrying depleted fluid away from the organ. The perfusion apparatus also includes a device operably associated with the perfusion circuit for maintaining the organ at a substantially normothermic temperature.
1. An organ preservation solution for the preservation of a human or human-compatible harvested organ in a functioning state comprising:
(1) a metabolizable carbohydrate at a concentration between 2.5% and 3%;
(2) sodium chloride at a concentration between 0.45% and 0.9%;
(3) potassium ion at a concentration between 4 meq/L and 10 meq/L;
(4) calcium ion at a concentration between 0.25 gm/L and 1.5 g/L;
(4) magnesium ion at a concentration between 0.5 gm/L and 0.7 gm/L;
(6) bicarbonate ion at a concentration between 10 meq/L and 20 meq/L;
(7) epinephrin at a concentration between 0.5 mg/L and 2 mg/L;
(8) adenosine at a concentration between 500 μmol/L and 1 mmol/L; and
(9) at least one fatty acid; wherein said solution is substantially free of non metabolizable impermeants; and further wherein said solution has a pH of about 7.4 to about 8.5.
2. A solution according to claim 1 wherein said solution further comprises a pharmaceutically active agent selected from the group consisting of heparin, nitroglycerin, an ACE inhibitor, a beta blocker, a calcium channel blocker, a cytoprotective agent, an antioxidant, an anti-fungal agent, an anti-viral agent, an anti-bacterial agent, an immunosuppressive agent, a nonsteroidal anti-inflammatory agent, a steroid, vitamins and mixtures thereof.
3. A solution according to claim 2 wherein said solution further includes insulin.
4. A solution according to claim 2 wherein said solution further includes a complement neutralizer.
5. A solution according to claim 2 wherein said metabolizable carbohydrate is glucose.
6. A method of preserving a human or human-compatible harvested organ in a functioning state during a preservation period prior to implantation comprising:
(a) providing an organ in need of preservation;
(b) providing containment means for said organ;
(c) providing a preservation fluid media; said fluid media comprising:
(i) whole blood or leukocyte-depleted whole blood that is compatible with said organ; and
(ii) a preservation solution comprising:
(a) a metabolizable carbohydrate;
(b) sodium chloride;
(c) potassium ion;
(d) calcium ion;
(e) magnesium ion;
(f) bicarbonate; epinephrin; and adenosine;
(d) delivering said fluid media to at least one major vessel of said contained functioning organ while said organ is maintained at a normothermic temperature of about 20° C. to about 37° C.
7. A method according to claim 6 wherein said media includes heparin.
8. A method according to claim 6 wherein said media further includes a pharmaceutically active agent selected from the group consisting of nitroglycerin, an ACE inhibitor, a beta blocker, a calcium channel blocker, a cytoprotective agent, an antioxidant, an anti-fungal agent, an anti-viral agent, an anti-bacterial agent, an immunosuppressive agent, a nonsteroidal anti-inflammatory agent, a steroid, and mixtures thereof.
9. A method according to claim 6 wherein said media further includes at least one fatty acid.
10. A method according to claim 9 wherein said method includes the further step of delivering said fluid media to the exterior of said organ.
11. A method according to claim 6 wherein said method includes the further step of filtering said fluid media as metabolic products from said organ accumulate in said fluid media.
12. A method according to claim 6 wherein said method includes the further step of oxygenation at least a part of said fluid media.
13. A method according to claim 6 wherein said method comprises the further step of measuring the flow of said fluid media.
14. A method according to claim 6 wherein said method comprises the further step of measuring the pressure of said fluid media.
15. A method according to claim 6 wherein the harvested organ is selected from the group consisting of heart, kidney, liver, lung, pancreas, small intestine, blood carrying vessel, and myocutaneous free flap.
16. A method according to claim 15 wherein the organ preserved is a heart.
17. A method of claim 6 wherein said media includes insulin.