Claims for Patent: 4,920,105

Summary for Patent: 4,920,105

Title:	Membrane pouch
Abstract:	A membrane pouch, for rehydrating sterile intravenous and other solutions for non-sterilized fresh water, has a double bag construction. An inner bag made of semipermeable membrane material holds the sterile solutes to be rehydrated. The membrane material is permeable by water but impermeable to contaminants and a large molecular weight solute contained in the bag. An outer waterproof bag encloses the membrane bag and serves as a container for fresh water. Each bag has a sealable valve for providing access to the interior thereof. A high molecular weight dye located in the outer bag provides a visible indication of the existence of any discontinuity in the membrane bag. A low molecular weight, water soluble, non-toxic substance having a high osmotic pressure can be placed inside the membrane bag to accelerate the osmotic transfer of sterile water from the outer bag into the inner membrane bag.
Inventor(s):	Zelman; Allen (Vienna, VA)
Assignee:	Rensselaer Polytechnic Insitute (Troy, NY)
Application Number:	07/071,666
Patent Claims:	1. A membrane pouch for producing a sterile solution from non-sterilized fresh water, the pouch comprising: a first closed bag of semipermeable membrane material, said membrane material being permeable to water molecules and impermeable to viruses, bacteria and pyrogens; a second, waterproof bag substantially enclosing said first bag; first sealable port means for providing access to a first compartment within said first bag; second sealable port means for providing access to a second compartment, said second compartment lying between said first bag and said second bag; and a sterile solute to be hydrated located in one of said first and second compartments, said solute comprising a large molecular weight osmotic agent which is impermeant to said membrane material and an osmotic accelerator, said osmotic accelerator comprising a non-toxic, water soluble, low molecular weight substance which is permeant to said membrane member and possesses a high osmotic pressure, said accelerator serving to initiate and accelerate hydrating of the osmotic agent, whereby fresh water placed in the other of said compartments is transferred by accelerated osmosis to said one of said compartments containing said solute while the membrane material precludes passage of bacteria, viruses and pyrogens therethrough. 2. The pouch of claim 1 wherein said large molecular weight osmotic agent comprises a polysaccharide and said osmotic accelerator is selected from the group consisting of mineral salts and sugars. 3. The pouch of claim 2 wherein said osmotic agent comprises a first quantity of dextran and said osmotic accelerator comprises a second quantity of sodium chloride, and wherein said first and second quantities are such as to produce a usable intravenous solution when rehydrated with fresh water from said second compartment. 4. A membrane pouch especially suitable for producing a sterile solution from non-sterilized fresh water, the pouch comprising: a first closed bag of semipermeable membrane material, said membrane material being permeable to water molecules and impermeable to viruses, bacteria and pyrogens; a second, waterproof bag substantially enclosing said first bag; first sealable port means for providing access to a first compartment within said first bag, said first port means extending through said second bag; second sealable port means for providing access to a second compartment, said second compartment lying between said first bag and said second bag, whereby fresh water placed in one of said first and second compartments can be transferred by osmosis to the other of said compartments while the membrane material precludes passage of bacteria, viruses and pyrogens therethrough; and indicator means for providing an indication if the first bag is not intact, said first and second bags being at least partially transparent, said indicator means providing a color indication of the existence of a discontinuity in the first bag. 5. The pouch of claim 4 wherein said indicator means comprises a dye placed in one of said first and second compartments, said dye being selected to have a molecular weight greater than the molecular weight cut-off of the membrane material such that the dye does not pass through the membrane material unless said material contains a discontinuity. 6. The pouch of claim 5 wherein the first bag is pleated. 7. The pouch of claim 6 wherein a portion of said first port means extends beyond said second bag, and said pouch further comprises a shield surrounding said portion of said first port means. 8. The pouch of claim 7 wherein said shield comprises a separable sealed extension of said second bag. 9. The pouch of claim 8 wherein said first port means comprises a hollow tube, said tube having one end which extends into said first bag and a second end which is provided with a removable cap. 10. The pouch of claim 8 wherein said first port means comprises a mouthpiece. 11. The pouch of claim 4 further comprising a solute desired to be rehydrated located in said first compartment. 12. The pouch of claim 11 wherein said first compartment and said solute are sterile. 13. The pouch of claim 12 wherein said solute comprises dehydrated mil,. 14. The pouch of claim 12 wherein said solute comprises a dehydrated pharmaceutical. 15. The pouch of claim 4 further comprising a sterile solute in said first compartment, said solute comprising a large molecular weight osmotic agent. 16. Apparatus for producing a sterile solution by hydrating a solute from non-sterilized fresh water, comprising: first sealable container means for receiving said solute; second waterproof container means for receiving nonsterilized fresh water; a semipermeable membrane member common to said first and second container means, said membrane member being permeable to water molecules and impermeable to bacteria, pyrogens, viruses and said solute; and an osmotic accelerator initially located in said first container means, said osmotic accelerator comprising a water soluble, non-toxic substance having a high osmotic pressure and being permeant to said membrane member, and wherein the osmotic accelerator serves to initially draw a first quantity of water from said second container means into said first container means through said semipermeable membrane member to wet said solute and said accelerator equilibrates throughout the water in said first and second container means, and said wet solute, through osmosis, draws water containing said equilibrated accelerator into said first container means through said membrane member. 17. The apparatus of claim 16 wherein said solute comprises a polysaccharide and said osmotic accelerator comprises a substance selected from the group consisting of mineral salts and sugars. 18. The apparatus of claim 17 wherein said solute comprises a first quantity of dextran and said osmotic accelerator comprises a second quantity of sodium chloride, and wherein said first and second quantities are such as to produce a usable intravenous solution when rehydrated with water from said second compartment. 19. The apparatus of claim 16 further comprising a dye indicator located in said second container means, said dye indicator being impermeant to said membrane member when said membrane member is intact, said dye indicator serving to provide a visible indication of the existence of a discontinuity in said membrane member. 20. A method of rehydrating a solute to produce a sterile aqueous solution of said solute from non-sterilized fresh water, comprising the steps of: separating a supply of non-sterilized fresh water from said solute by a semipermeable membrane member; employing a membrane material which is permeable to water and impermeable to said solute and to contaminants such as bacteria, virus and pyrogens, as said membrane member; and initiating and accelerating the osmotic transfer of sterile water from said water supply through said membrane member by including a non-toxic, water soluble substance having a high osmotic pressure and being permeant to said membrane member with said solute. 21. The method of claim 20 further comprising the step of adding a dye to said water supply, said dye being impermeant to said membrane member when said member is intact, said dye serving as a failsafe mechanism to visibly indicate the existence of any discontinuity in said membrane member. 22. The method of claim 20 further comprising the step of agitating said water supply, membrane member, solute and osmotic accelerator. 23. The method of claim 22 wherein said solute comprises a polysaccharide and said osmotic accelerator comprises a substance chosen from a group comprising mineral salts and sugars. 24. The method of claim 23 wherein said solution comprises a plasma substitute for intravenous injection, said solute comprises dextran and said osmotic accelerator comprises sodium chloride.

Details for Patent 4,920,105

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2039-09-23