US2006160724A1PendingUtilityA1

Preserving a hemoglobin blood substitute with a transparent overwrap

Individually held — no corporate assignee on recordPriority: Mar 23, 1995Filed: Mar 21, 2006Published: Jul 20, 2006
Est. expiryMar 23, 2015(expired)· nominal 20-yr term from priority
A01N 1/146A01N 1/10B32B 27/18B32B 27/304B32B 2535/00B32B 15/08B32B 2307/7244B32B 27/08A61K 35/00B32B 27/32A61K 38/42B32B 2264/102B32B 27/36B32B 2439/80B32B 2250/24A61J 1/05B32B 2307/412C07K 14/805
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Claims

Abstract

The invention relates to a method for preserving the stability of a hemoglobin blood substitute comprising maintaining the hemoglobin blood substitute in an atmosphere substantially free of oxygen. The method for preserving the deoxygenated hemoglobin blood substitute comprises maintaining the deoxygenated blood substitute in an oxygen barrier film overwrap package, wherein at least one face of the overwrap package comprises a transparent laminate material and wherein at least one other face of the overwrap package comprises a foil laminate material. The preserved deoxygenated hemoglobin blood substitute comprises a deoxygenated hemoglobin blood substitute and an oxygen barrier film overwrap package wherein at least one face of the overwrap package comprises a transparent laminate material and wherein at least one other face of the overwrap package comprises a foil laminate material.

Claims

exact text as granted — not AI-modified
1 . A method for preserving a deoxygenated hemoglobin blood substitute comprising maintaining a deoxygenated hemoglobin blood substitute, that is contained within a primary package, in an oxygen barrier film overwrap that includes a transparent laminate material and a foil laminate material that together form a chamber, wherein the transparent laminate material includes a flexed silicon oxide layer and wherein the primary package and the blood substitute contained therein are sealed within the chamber between the foil laminate material and the transparent laminate material of the oxygen barrier film overwrap.  
   
   
       2 . The method of  claim 1 , wherein the transparent laminate material further includes a polyester layer.  
   
   
       3 . The method of  claim 2 , wherein the transparent laminate material further includes a linear low density polymer layer.  
   
   
       4 . The method of  claim 3 , wherein the linear low density polymer layer is selected from the group consisting of polyethylene, polypropylene, and copolymers thereof.  
   
   
       5 . The method of  claim 4 , wherein linear low density polymer payer is linear low density polyethylene.  
   
   
       6 . The method of  claim 5 , wherein the transparent laminate material and foil laminate material are continuously bonded at a perimeter of the oxygen barrier film overwrap.  
   
   
       7 . The method of  claim 6 , wherein the oxygen barrier film overwrap has an oxygen permeability of less than about 0.01 cc per 645 cm 2  per 24 hours per atmosphere at 23° C.  
   
   
       8 . The method of  claim 7 , wherein the oxygen barrier film overwrap has an oxygen permeability of less than about 0.0005 cc per 645 cm 2  per 24 hours per atmosphere at 25° C.  
   
   
       9 . The method of  claim 8 , wherein the silicon oxide layer has a thickness in a range of between about 100 Å and about 2000 Å.  
   
   
       10 . The method of  claim 9 , wherein the polyethylene layer has a thickness of between about 0.013 and about 0.254 millimeters.  
   
   
       11 . The method of  claim 10 , wherein the polyethylene layer has a thickness of about 0.0508 millimeters.  
   
   
       12 . The method of  claim 10 , wherein the oxygen permeability of the oxygen barrier film overwrap is less than about 0.0005 cc per 645 cm 2  per 24 hours per atmosphere at 25° C. and 100%/50% inside/outside relative humidity.  
   
   
       13 . The method of  claim 12 , wherein the transparent laminate material has an oxygen permeability of about 0.0005 cc per 645 cm 2  per atmosphere per day at 25° C. and 100%/50% inside/outside relative humidity.  
   
   
       14 . The method of  claim 13 , wherein the hemoglobin blood substitute is maintained under a nitrogen, argon or helium atmosphere.  
   
   
       15 . A preserved deoxygenated hemoglobin blood substitute, comprising: 
 a) a deoxygenated hemoglobin-blood substitute contained within a primary package; and    b) an oxygen barrier film overwrap package that includes a transparent laminate material and a foil laminate material that together form a chamber, wherein the transparent laminate material includes a fused silicon oxide layer and wherein the primary package and the blood substitute contained therein are sealed within the chamber between the foil laminate material and the transparent laminate material, thereby preserving the deoxygenated hemoglobin blood substitute in an environment that is substantially free of oxygen.    
   
   
       16 . The preserved deoxygenated hemoglobin blood substitute of  claim 15 , wherein the transparent laminate material further includes a polyester layer.  
   
   
       17 . The preserved deoxygenated hemoglobin blood substitute of  claim 16 , wherein the transparent laminate material further includes a linear low density polymer layer.  
   
   
       18 . The preserved deoxygenated hemoglobin blood substitute of  claim 17 , wherein the linear low density polymer layer is selected from the group consisting of polyethylene, polypropylene, and copolymers thereof.  
   
   
       19 . The preserved deoxygenated hemoglobin blood substitute of  claim 18 , wherein linear low density polymer payer is a linear low density polyethylene.  
   
   
       20 . The preserved deoxygenated hemoglobin blood substitute of  claim 19 , wherein the transparent laminate material and foil laminate material are continuously bonded at a perimeter of the oxygen barrier film overwrap.  
   
   
       21 . The preserved deoxygenated hemoglobin blood substitute of  claim 20 , wherein the oxygen barrier film overwrap has an oxygen permeability of less than about 0.01 cc per 645 cm 2  per 24 hours per atmosphere at 23° C.  
   
   
       22 . The preserved deoxygenated hemoglobin blood substitute of  claim 21 , wherein the oxygen barrier film overwrap has an oxygen permeability of less than about 0.0005 cc per 645 cm 2  per 24 hours per atmosphere at 25° C.  
   
   
       23 . The preserved deoxygenated hemoglobin blood substitute of  claim 22 , wherein the silicon oxide layer has a thickness in a range of between about 100 Å and about 2000 Å.  
   
   
       24 . The preserved deoxygenated hemoglobin blood substitute of  claim 22 , wherein the polyethylene layer has a thickness of between about 0.013 and about 0.254 millimeters.  
   
   
       25 . The preserved deoxygenated hemoglobin blood substitute of  claim 24 , wherein the polyethylene layer has a thickness of about 0.0508 millimeters.  
   
   
       26 . The preserved deoxygenated hemoglobin blood substitute of  claim 24 , wherein the oxygen permeability of the oxygen barrier film overwrap is less than about 0.0005 cc per 645 cm 2  per 24 hours per atmosphere at 25° C. and 100%/50% inside/outside relative humidity.  
   
   
       27 . The preserved deoxygenated hemoglobin blood substitute of  claim 26 , wherein the transparent laminate material has an oxygen permeability of about 0.0005 cc per 645 cm 2  per atmosphere per day at 25° C. and 100%/50% inside/outside relative humidity.  
   
   
       28 . The preserved deoxygenated hemoglobin blood substitute of  claim 27 , wherein the hemoglobin blood substitute is maintained under a nitrogen, argon or helium atmosphere.

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