Claims
- 1. A composition comprising a storage-stable organ preservation solution, comprising a biologically effective amount of substantially linear polyethylene glycol that is essentially free of decomposition products.
- 2. The composition according to claim 1 in which the linear polyethylene glycol is present in a concentration in the range of from about 0.1% to about 20% by weight.
- 3. The composition according to claim 2 in which the linear polyethylene glycol is present in a concentration in the range of from about 2% to about 15% by weight.
- 4. The composition according to claim 3 in which the linear polyethylene glycol is present in a concentration of between about 7% and 8% by weight.
- 5. The composition according to claim 1 in which the linear polyethylene glycol has an average molecular weight of greater than approximately 8,000 Daltons.
- 6. The composition according to claim 5 in which the linear polyethylene glycol is present in a concentration in the range of from about 2% to about 15% by weight.
- 7. The composition according to claim 1 in which the linear polyethylene glycol has an average molecular weight in the range of approximately 20,000 to approximately 35,000 Daltons.
- 8. The composition according to claim 1 in which the linear polyethylene glycol has an average molecular weight of approximately 20,000 Daltons and is present in a concentration of between approximately 7% and approximately 8% by weight.
- 9. The composition according to any of claims 1 to 8 in which the decomposition products are present in a concentration sufficiently low that four hour storage of isolated rabbit hearts with the composition results in less than about a 30% decrease in cardiac output compared to untreated hearts that are not stored.
- 10. The composition according to claim 1 which is storage-stable for at least about 12 months when stored anoxically in the absence of exposure to UV light at a temperature of about 4° C.
- 11. A composition comprising a storage-stable aqueous solution for the preservation of organs, comprising from about 0.1% to about 20% by weight of linear polyethylene glycol having an average molecular weight greater than approximately 8,000 Daltons and essentially free of decomposition products, further comprising an effective amount of at least one of the following additional components:
(a) a buffer; (b) an impermeant anion; (c) a component providing phosphate; (d) a component providing potassium; (e) a component controlling cell swelling; and (f) a component providing magnesium.
- 12. The composition according to claim 11 wherein the additional components comprise at least one of the following:
(a) NaOH; (b) Lactobionic acid; (c) KH2PO4; (d) KOH; (e) Raffinose; (f) MgSO4; and (g) para-hydroxyanisole.
- 13. The composition according to claim 11 wherein the additional components comprise at least one of the following:
(a) NaOH, about 5-125 mM; (b) Lactobionic acid, about 80-120 mM; (c) KH2PO4, about 5-50 mM; (d) KOH, about 5-125 mM; (e) Raffinose, about 25-35 mM; (f) MgSO4, about 4-6 mM; and (g) para-hydroxyanisole, about 0.04 mM.
- 14. The composition according to claims 11, 12 or 13, further comprising at least one of the following additional components:
(h) an antioxidant; (i) an iron chelator; and (j) a vasodilator.
- 15. The composition according to claim 14 wherein the additional components are selected from the group consisting of
(h) desferoxamine; and (i) nitroglycerin.
- 16. The composition according to claim 14 wherein the additional components are selected from the group consisting of
(h) Desferoxamine, 5-9 μM; and (i) Nitroglycerin, 2-3 mg/l.
- 17. A method for preparing a storage-stable aqueous solution for the preservation of organs, comprising the steps of:
reducing the level of contaminating materials in a sample of linear polyethylene glycol; combining the linear polyethylene glycol in an organ preservation solution to obtain a final concentration of linear polyethylene glycol from about 0.1% to 20%; and storing the aqueous solution obtained under anoxic conditions in the absence of UV light.
- 18. The method according to claim 17 in which the decomposition products are reduced by ultrafiltration.
- 19. The method according to claim 17 in which the decomposition products are reduced by dialysis.
- 20. The method according to claim 17, wherein said linear polyethylene glycol has an average molecular weight of greater than approximately 8,000 Daltons.
- 21. The method according to claim 17, wherein a 10% by weight solution of said linear polyethylene glycol in distilled water has a conductivity of less than 20 μS/cm.
- 22. The method according to claim 17, wherein said linear polyethylene glycol comprises less than 2 mole-percent of aldehydes.
- 23. A method for preserving an organ intended for transplantation, comprising contacting the organ with a storage stable aqueous solution comprising from about 0.1% to 20% by weight of linear polyethylene glycol (PEG) having an average molecular weight greater than approximately 8,000 Daltons and essentially free of decomposition products.
- 24. The method according to claim 23 wherein the vascular system of the organ is flushed with the solution immediately prior to removal from a donor.
- 25. The method according to claim 23 wherein the vascular system of the organ is contacted with a solution not containing PEG prior to removal from a donor and contacted with the solution containing PEG following removal from a donor.
- 26. The method according to claim 23 wherein the organ is a heart.
- 27. A method for cardioplegia, comprising contacting a heart with an aqueous solution comprising from about 0.1% to 20% by weight of linear polyethylene glycol having an average molecular weight greater than approximately 8,000 Daltons and essentially free of decomposition products.
- 28. A method of organ preservation, comprising; adding a biologically effective amount of substantially linear polyethylene glycol having an average molecular weight greater than approximately 8,000 Daltons and essentially free of decomposition products to the solution in which the organ is stored.
- 29. A method of organ preservation, comprising; administering to the host animal at least one intravenous bolus of a biologically effective amount of substantially linear polyethylene glycol having an average molecular weight greater than approximately 8,000 Daltons.
- 30. A method of treatment of a patient, comprising; administering to the patient a biologically effective amount of substantially linear polyethylene glycol having an average molecular weight greater than approximately 8,000 Daltons.
- 31. A method of treating an organ transplant recipient comprising administering to the recipient an amount of a composition comprising a substantially linear polyethylene glycol, having an average molecular weight greater than approximately 8,000 Daltons and essentially free of decomposition products, effective to enhance function of the transplanted organ.
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Applications No. 06/038,381, filed Feb. 13, 1997, Ser. No. 06/038,422, filed Feb. 18, 1997, and Ser. No. 06/065,586, filed Nov. 18, 1997.
Provisional Applications (3)
|
Number |
Date |
Country |
|
60038381 |
Feb 1997 |
US |
|
60038422 |
Feb 1997 |
US |
|
60065586 |
Nov 1997 |
US |