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  Preserving a hemoglobin blood substitute with a transparent overwrapUSPTO Application #: 20060160724Title: Preserving a hemoglobin blood substitute with a transparent overwrap 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. (end of abstract) Agent: Hamilton, Brook, Smith & Reynolds, P.C. - Concord, MA, US Inventors: Maria S. Gawryl, Robert A. Houtchens, William R. Light USPTO Applicaton #: 20060160724 - Class: 514006000 (USPTO) Related Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Designated Organic Active Ingredient Containing (doai), Peptide Containing (e.g., Protein, Peptones, Fibrinogen, Etc.) Doai, Heavy Metal Containing (e.g., Hemoglobin, Etc.) The Patent Description & Claims data below is from USPTO Patent Application 20060160724. Brief Patent Description - Full Patent Description - Patent Application Claims
RELATED APPLICATIONS [0001] This application is a Continuation of U.S. application Ser. No. 10/018,529 filed on Jun. 3, 2002, which is a national stage application of PCT/US00/18750 filed on Jul. 7, 2000, which is a Continuation of U.S. patent application Ser. No. 09/349,290, filed on Jul. 7, 1999, which is a Continuation-in-Part of U.S. patent application Ser. No. 09/173,189, filed on Oct. 14, 1998, which is a Continuation-in-Part of U.S. patent application Ser. No. 08/974,658, filed on Nov. 19, 1997 now abandoned, which is a Continuation of U.S. patent application Ser. No. 08/471,583, filed Jun. 7, 1995 now issued U.S. Pat. No. 5,691,452, which is a Continuation-in-Part of U.S. patent application Ser. No. 08/458,916, filed Jun. 2, 1995 now issued U.S. Pat. No. 5,840,582, which is a Continuation of U.S. patent application Ser. No. 08/409,337, filed Mar. 23, 1995 now issued U.S. Pat. No. 5,854,209. The entire teachings of the above-mentioned applications are incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] There exists a need for a blood-substitute to treat or prevent hypoxia resulting from blood loss (e.g, from acute hemorrhage or during surgical operations), resulting from anemia (e.g., pernicious anemia or sickle cell anemia), or resulting from shock (e.g, volume deficiency shock, anaphylactic shock, septic shock or allergic shock). The use of blood and blood fractions as in these capacities as a blood-substitute is fraught with disadvantages. For example, the use of whole blood often is accompanied by the risk of transmission of hepatitis-producing viruses and AIDS-producing viruses which can complicate patient recovery or result in patient fatalities. Additionally, the use of whole blood requires blood-typing and cross-matching to avoid immunohematological problems and interdonor incompatibility. [0003] Human hemoglobin, as a blood-substitute, possesses osmotic activity and the ability to transport and transfer oxygen, but it has the disadvantage of rapid elimination from circulation by the renal route and through vascular walls, resulting in a very short, and therefore, a typically unsatisfactory half-life. Further, human hemoglobin is also frequently contaminated with toxic levels of endotoxins, bacteria and/or viruses. [0004] Non-human hemoglobin suffers from the same deficiencies as human hemoglobin. In addition, hemoglobin from non-human sources is also typically contaminated with proteins, such as antibodies, which could cause an immune system response in the recipient. [0005] Previously, at least four other types of blood-substitutes have been utilized, including perfluorochemicals, synthesized hemoglobin analogues, liposome-encapsulated hemoglobin, and chemically-modified hemoglobin. However, many of these blood-substitutes have typically had short intravascular retention times, being removed by the circulatory system as foreign substances or lodging in the liver, spleen, and other tissues. Also, many of these blood-substitutes have been biologically incompatible with living systems. [0006] Thus, in spite of the recent advances in the preparation of hemoglobin-based blood-substitutes, the need has continued to exist for a blood-substitute which has levels of contaminants, such as endotoxins, bacteria, viruses, phospholipids and non-hemoglobin proteins, which are sufficiently low to generally prevent an immune system response and any toxicological effects resulting from an infusion of the blood-substitute. In addition, the blood-substitute must also be capable of transporting and transferring adequate amounts of oxygen to tissues under ambient conditions and must have a good intravascular retention time. [0007] Further, it is preferred that the blood-substitute 1) has an oncotic activity generally equivalent to that of whole blood, 2) can be transfused to most recipients without cross-matching or sensitivity testing, and 3) can be stored with minimum amounts of refrigeration for long periods. [0008] The blood-substitute is typically packaged in a metal foil laminate overwrap having high O.sub.2 and moisture barrier properties. The metal foil laminates are typically opaque, thus not allowing visual inspection of the product nor the inspection of the integrity of the primary package. Furthermore, an opaque overwrap requires the use of a second label on the outside of the overwrap. [0009] In the past, clear silicon containing laminates with high oxygen and moisture barrier properties have not been useful in automated packaging equipment because the stress on the material caused it to crack or otherwise lose barrier properties. SUMMARY OF THE INVENTION [0010] The present invention is drawn to a method for preserving a deoxygenated hemoglobin blood substitute. The method comprises maintaining a packaged deoxygenated hemoglobin blood substitute in an oxygen barrier film overwrap package wherein the package comprises a foil laminate material and a transparent laminate material. In one embodiment, the oxygen barrier film overwrap has an oxygen permeability of less than about 0.01 cubic centimeters per 100 square inches (or 0.01 cc per 645 square centimeters) over 24 hours at one atmosphere and at room temperature. Room temperature is defined herein as about 23.degree. C. In one embodiment, at least one face of the overwrap comprises a transparent laminate material and at least one other face of the overwrap comprises a foil laminate material. In one embodiment of the present invention, the overwrap is produced by forming the foil laminate material to define at least one chamber. The packaged deoxygenated hemoglobin blood substitute is placed into the chambers of said foil. The transparent laminate material is then heat sealed to the foil laminate comprising chambers containing the packaged hemoglobin blood substitute, thereby containing the packaged blood substitute within the overwrap. [0011] The present invention also is drawn generally to a preserved deoxygenated hemoglobin blood substitute. The preserved blood substitute of the present invention comprises a packaged deoxygenated hemoglobin blood substitute and an oxygen barrier film overwrap package. In one embodiment, the oxygen barrier film overwrap of the preserved deoxygenated hemoglobin blood substitute comprises a transparent laminate material having an oxygen permeability of less than about 0.01 cubic centimeters per 100 square inches (or about 0.01 cc per 645 square centimeters) over 24 hours at one atmosphere and at room temperature. The packaged deoxygenated hemoglobin blood substitute is sealed within said oxygen barrier film overwrap, thereby preserving the deoxygenated hemoglobin blood substitute in an environment that is substantially free of oxygen. In one embodiment, at least one face or sheet of the overwrap comprises a transparent laminate material and at least one other face of the overwrap comprises a foil laminate material. The overwrap is produced by forming the foil laminate material to define at lest one chamber. The packaged deoxygenated hemoglobin blood substitute is then placed into the chambers of said foil. The transparent laminate material is then heat sealed to the foil laminate containing said deoxygenated hemoglobin blood substitute, forming the preserved deoxygenated hemoglobin blood substitute of the present invention. [0012] In one embodiment of the present invention, the transparent laminate material is used in combination with foil laminate material in automated packaging. In one embodiment, a automated packaging machine manufactured by Tiromat (Avon, Mass.) has been used. [0013] The advantages of this invention are numerous. One advantage is that the hemoglobin stored according to the methods of this invention has a greater degree of purity and longer shelf-life. High barrier overwraps provide an addition level of product quality even when high barrier primary packaging is employed. In addition, the transparent high barrier overwraps of the present invention provide extremely high oxygen and water vapor barrier properties but have no saran (polyvinylidene chloride, PVDC) layer. PVDC poses a medical waste problem because chlorinated products such as polycyclic aromatic hydrocarbons and hydrochloric acid are generated during incineration. Overwraps comprising at least one clear face, or region or side allow the label of the primary package to be seen. Therefore, a second label is typically not required on the overwrap. In addition, product quality inspection and primary package integrity can also be evaluated. Furthermore, as demonstrated for the first time herein, automation equipment can be used with the clear oxygen barrier laminates, allowing production of very large numbers of packages with high oxygen barrier properties in a short period of time with very little human labor and without the loss of barrier properties. The blood-substitute remains stable at room temperature for periods of two years or more, a significant improvement over previous methods. DETAILED DESCRIPTION OF THE INVENTION [0014] The features and other details of the process of the invention will now be more particularly described and pointed out in the claims. It will be understood that the particular embodiments of the invention are shown by way of illustration and not as limitations of the invention. The principle features of this invention can be employed in various embodiments without departing from the scope of the present invention. [0015] 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. This method can be accomplished by maintaining the blood substitute in an oxygen-impermeable container, such as an oxygen barrier primary package, an oxygen barrier film overwrap (e.g., a bag), glass container (e.g., a vial) or a steel container. Where the primary package is an oxygen barrier film, the container can be manufactured from a variety of materials, including polymer films, (e.g., an essentially oxygen-impermeable polyester, ethylene vinyl alcohol (EVOH), or nylon), and laminates thereof. Where the container is an oxygen barrier overwrap, the container can be manufactured from a variety of materials, including polymer films, (e.g., an essentially oxygen-impermeable polyester, ethylene vinyl alcohol (EVOH), or nylon) and laminates, such as a transparent laminate (e.g. a silicon oxide or EVOH containing laminate) or a metal foil laminate (e.g., a silver or aluminum foil laminate) or a combination of transparent laminate and a metal foil laminate. [0016] Where the overwrap is a film, such as a polyester film, the film can be rendered essentially oxygen-impermeable by a variety of suitable methods. In one embodiment, the film as manufactured is essentially oxygen-impermeable. Alternatively, where the polymeric material is not sufficiently oxygen-impermeable to meet the desired specifications, the film can be laminated or otherwise treated to reduce or eliminate the oxygen permeability. [0017] In a preferred embodiment, a transparent laminate is employed for at least one face of the overwrap. In one embodiment, at least one layer of the transparent laminate comprises silicon dioxide. The oxygen barrier layer preferably has a thickness between about 100 and about 2000 .ANG.. For both the primary package and the overwrap, the laminate typically contains one or more polymeric layers. The polymer can be a variety of polymeric materials including, for example, a polyester layer (e.g., a 48 gauge polyester), nylon or a polyolefin layer, such as polyethylene, ethylene vinyl acetate, or polypropylene or copolymers thereof. [0018] The overwraps of the present invention can be of a variety of constructions, including vials, cylinders, boxes, etc. In a preferred embodiment, the container is in the form of a bag. A suitable bag can be formed by continuously bonding one or more (e.g., two) sheets at the perimeter(s) thereof to form a tightly closed, oxygen impermeable, construction having a fillable center. The shape of the bag can be those routinely encountered in that art. In the case of laminates comprising polyolefins, such as linear low density, low density, medium or high density polyethylene or polypropylene and copolymers thereof, the perimeter of the bag is bonded or sealed using heat. It is well within the skill of the art to determine the appropriate temperature to generate a tightly closed, oxygen and/or moisture impermeable construction. [0019] The present invention is drawn to a method for preserving a deoxygenated hemoglobin blood substitute and to preserved deoxygenated hemoglobin blood substitutes. The method of the present invention comprises maintaining the deoxygenated hemoglobin blood substitute in an oxygen barrier film overwrap, wherein at least one face of the overwrap comprises a transparent laminate material and wherein at least one other face of the overwrap comprises a foil laminate material. In one embodiment of the present invention, the overwrap is produced by forming at least one chamber in the foil laminate material and placing the deoxygenated hemoglobin blood substitute into said chambers, wherein the hemoglobin is contained within a primary package. The transparent laminate material is then heat sealed onto the foil laminate material containing chambers and said hemoglobin blood substitute. In one embodiment of the present invention the transparent laminate material comprises a silicon oxide coated polyester film. In another embodiment of the present invention, the hemoglobin blood substitute is maintained under a nitrogen, argon or helium atmosphere. [0020] The preserved deoxygenated hemoglobin blood substitute of the present invention comprises a deoxygenated hemoglobin substitute and an oxygen barrier film overwrap package wherein at least one face of the overwrap comprises a transparent laminate material and wherein at least one other face of the overwrap comprises a foil laminate material. In one embodiment of the present invention, the preserved deoxygenated hemoglobin blood substitute comprises a transparent laminate material comprising a silicon oxide coated polyester film. In another embodiment, the preserved blood substitute is maintained under a nitrogen, argon or helium atmosphere. In still another embodiment of the present invention, the overwrap of the preserved deoxygenated hemoglobin blood substitute is produced by forming at least one chamber in the foil laminate material. The deoxygenated hemoglobin blood substitute is placed into the chambers of said foil wherein the deoxygenated hemoglobin blood substitute is contained in a primary package. The transparent laminate material is then heat sealed to the foil laminate material having chambers and containing said deoxygenated hemoglobin blood substitute. Continue reading... Full patent description for Preserving a hemoglobin blood substitute with a transparent overwrap Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Preserving a hemoglobin blood substitute with a transparent overwrap patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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