Claims for Patent: 8,012,677
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Summary for Patent: 8,012,677
Title: | Evaluation and preservation solution |
Abstract: | An evaluation and preservation solution for human and animal organs, tissues and parts thereof is described, wherein it comprises serum albumin at a concentration of 55-105 g/L, a scavenger and coating compound, preferably dextran compounds and derivatives thereof having essentially the same structure at a concentration of 1-55 g/L weight, and a physiological serum concentration of salts and nutrients in a physiologically acceptable medium. |
Inventor(s): | Steen; Stig (Lund, SE) |
Assignee: | XVIVO Perfusion AB (Gothenburg, SE) |
Application Number: | 11/889,460 |
Patent Claims: | 1. A method of perfusing an organ, tissue, or part thereof, of an animal or human, the method comprising: evaluating the organ, tissue, or part thereof; and perfusing
the organ, tissue, or part thereof at normothermia by recirculation with a solution, wherein the organ, tissue, or part thereof is connected to a heart-lung machine during the perfusion, and wherein the solution comprises: (a) serum albumin at a
concentration of 55-105 g/L; (b) a scavenger and coating compound, which coats the capillary endothelium of the organ, tissue, or part thereof, at a concentration of 1-55 g/L; (c) a physiological serum concentration of a salt; and (d) a nutrient for
the organ, tissue, or part thereof, in a physiologically acceptable medium; wherein the solution provides an oncotic pressure higher than an applied hydrostatic pressure in the organ, tissue, or part thereof, and wherein the solution prevents oedema
formation.
2. The method of claim 1, wherein the concentration of the serum albumin is 65-85 g/L and the concentration of the scavenger and coating compound is 2-20 g/L. 3. The method of claim 1, wherein the salt comprises one or more of sodium, potassium, calcium, magnesium, phosphate, hydrogen carbonate and chloride ions; and the nutrient comprises one or more of physiologically acceptable carbohydrates, fatty acids and amino acids. 4. The method of claim 3, wherein the physiologically acceptable carbohydrate is glucose. 5. The method of claim 1, wherein the solution further comprises one or more of the following: a vasodilator; an antibiotic; a fibrinolytic component; a thrombocyte receptor blocker; a hormone; an insulin; a cortisol; a growth hormone; an anabolic steroid; or a combination thereof. 6. The method of claim 1, wherein the solution further comprises a pure scavenger compound. 7. The method of claim 1, wherein the serum albumin is human or animal serum albumin or recombinant serum albumin produced by genetic engineering. 8. The method of claim 1, wherein the organ is a lung, a heart, a kidney, a liver, a pancreas, or small bowels. 9. The method of claim 1, wherein the scavenger and coating compound has a molecular weight ranging from 1 to 250 kDa. 10. The method of claim 1, wherein the scavenger and coating compound has a molecular weight ranging from 15 to 115 kDa. 11. The method of claim 1, wherein the concentration of serum albumin is 70 g/L. 12. The method of claim 1, wherein the concentration of the scavenger and coating compound is 5 g/L. 13. The method of claim 1, wherein the solution further comprises papaverine, alteplase, abciximab, tyroxin/triiodotyronin, or a combination thereof. 14. The method of claim 1, wherein the concentration of the serum albumin is 65-85 g/L; the concentration of the scavenger and coating compound is 2-20 g/L; and the scavenger and coating compound has a molecular weight ranging from 20-150 kDa. 15. The method of claim 1, wherein the evaluating comprises measuring evaluation parameters of the organ, tissue, or part thereof for transplantation thereof. 16. The method of claim 15, further comprising preserving the organ, tissue or part thereof in said solution until the transplantation. 17. The method of claim 15, wherein the organ is a lung. 18. The method of claim 1, wherein the organ, tissue, or part thereof is harvested from a non-heart-beating animal or human donor, and the evaluating comprises evaluating if the organ, tissue,. or part thereof is acceptable for transplantation; and further comprising transplanting the organ, tissue, or part thereof into a receiver body. 19. The method of claim 18, further comprising preserving the organ, tissue or part thereof in said solution until the transplantation. 20. The method of claim 18, wherein the organ, tissue or part thereof is auto-, allo- or xenotransplanted. 21. The method of claim 1 wherein the solution further comprises red blood cells with an erythrocyte volume fraction of 15%.+-.5%. 22. The method of claim 21, wherein the concentration of the serum albumin is 60-80 g/L. 23. The method of claim 21, wherein the concentration of the scavenger and coating compound is 2-20 g/L. 24. The method of claim 21, wherein the scavenger and coating compound has a molecular weight ranging from 20 to 150 kDa. 25. The method of claim 21, wherein the concentration of serum albumin is 60-80 g/l and the concentration of the scavenger and coating compound is 2-20 g/L. 26. The method of claim 21, wherein the salt comprises one or more of sodium, potassium, calcium, magnesium, phosphate, hydrogen carbonate and chloride ions; and the nutrient comprises one or more of physiologically acceptable carbohydrates, fatty acids and amino acids. 27. The method of claim 21, wherein the solution further comprises one or more of the following: a vasodilator, an antibiotic, a fibrinolytic component, a thrombocyte receptor blocker, a hormone, an insulin, a cortisol, a growth hormone, an anabolic steroid or a combination thereof. 28. The method of claim 21, wherein the solution further comprises a pure scavenger compound. 29. The method of claim 21, wherein the serum albumin is human serum albumin or an animal serum albumin or recombinant serum albumin produced by genetic engineering. 30. The method of claim 21, wherein the solution further comprises a hyaluronic acid-based compound having a molecular weight of about 69 kDa. 31. The method of claim 21, wherein the organ is a lung, a heart, a kidney, a liver, a pancreas, or small bowels. 32. The method of claim 21, wherein the concentration of serum albumin is 60-80 g/L; the concentration of the scavenger and coating compound is 2-20 g/L; and the scavenger and coating compound has a molecular weight ranging from 20-150 kDa. 33. The method of claim 21, wherein the evaluating comprises measuring evaluation parameters of the organ, tissue, or part thereof for transplantation thereof. 34. The method of claim 33, further comprising preserving the organ, tissue or part thereof in said solution until the transplantation. 35. The method of claim 33, wherein the organ is a lung. 36. The method of claim 21, wherein the organ, tissue, or part thereof is harvested from a non-heart-beating animal or human donor, and the evaluating comprises evaluating if the organ, tissue,. or part thereof is acceptable for transplantation; and further comprising transplanting the organ, tissue, or part thereof into a receiver body. 37. The method of claim 36, further comprising preserving the organ, tissue or part thereof in said solution until the transplantation. 38. The method of claim 36, wherein the organ, tissue or part thereof is auto-, allo- or xenotransplanted. |
Details for Patent 8,012,677
Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Approval Date | Patent No. | Expiredate |
---|---|---|---|---|---|---|---|
Grifols Therapeutics Llc | ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5 | albumin (human) | For Injection | 101138 | 10/21/1942 | ⤷ Try a Trial | 2020-11-03 |
Baxalta Us Inc. | BUMINATE, FLEXBUMIN | albumin (human) | Injection | 101452 | 03/03/1954 | ⤷ Try a Trial | 2020-11-03 |
Csl Behring Ag | ALBURX | albumin (human) | Injection | 102366 | 07/23/1976 | ⤷ Try a Trial | 2020-11-03 |
Grifols Biologicals Llc | ALBUTEIN | albumin (human) | Injection | 102478 | 08/15/1978 | ⤷ Try a Trial | 2020-11-03 |
Genentech, Inc. | ACTIVASE | alteplase | For Injection | 103172 | 11/13/1987 | ⤷ Try a Trial | 2020-11-03 |
>Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Approval Date | >Patent No. | >Expiredate |
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