Claims for Patent: 5,484,431

Summary for Patent: 5,484,431

Title:	System for creating at a site, remote from a sterile environment, a parenteral solution
Abstract:	The present invention relates to a container, system, and method for creating parenteral solutions at a site, remote from sterile environments. The system includes a flexible container that is empty except for a prepackaged amount of a solute that is housed in the interior of the container. The container includes at least one port and a sterilizing filter in communication with an interior of the port. The container is so constructed and arranged that a fluid flow path is created from the port through the filter and into the interior of the container. A sterile water source including means for establishing fluid flow from the sterile water source into the port is provided. Accordingly, sterile water can flow from the sterile water source through the filter into the container where it is mixed with the solute to create a parenteral solution that can then be infused into a patient. A method and container are also provided.
Inventor(s):	Scharf; Mike (McHenry, IL), Finley; Mike (Park City, IL), Veillon; Joe (McHenry, IL), Kipp; Jim (Palatine, IL), Dudar; Tom (Palatine, IL), Owens; Jim (McHenry, IL), Ogle; Jim (Glenview, IL)
Assignee:	The United States of America as represented by the Administrator of the (Washington, DC)
Application Number:	07/647,109
Patent Claims:	1. A system for creating at a site, remote from a sterile environment, a parenteral solution in a large volume parenteral container comprising: a flexible container having an interior that is empty prior to adding a fluid except for a prepackaged amount of a solute that is housed in the interior of the container, the container including at least one port, and a sterilizing filter in fluid communication with the interior and the port, the container being so constructed and arranged that the fluid flows from the port, through the filter and into the interior of the container; and a source of sterile water including means for establishing fluid flow from the source of sterile water into the port. 2. The system of claim 1 wherein the solute is a powder. 3. The system of claim 1 wherein the solute is a liquid concentrate. 4. The system of claim 1 wherein the solute includes a component chosen from the group consisting of: dextrose; sodium chloride; and lactated Ringer's. 5. The system of claim 1 wherein the container includes means for defining at least two areas in the interior of the container that are in fluid communication. 6. The system of claim 1 wherein the interior of the container includes a sealed portion that allows fluid flow across a bottom portion and a top portion of the seal. 7. The system of claim 1 wherein the container includes at least one medication port and an administration port. 8. The system of claim 1 wherein the parenteral solution created is chosen from the group consisting of: saline; dextrose; and lactated Ringer's. 9. The system of claim 1 wherein the filter and the port are integral. 10. The system of claim 1 wherein the filter is removably secured to the container. 11. A system for creating at a site, remote from a sterile environment, a parenteral solution in a large volume parenteral container comprising: a flexible container including an interior that is empty prior to adding a fluid except for a prepackaged amount of a solute and a means for creating turbulence wherein the means for creating turbulence forms a flow path within the interior, the container in fluid communication with a sterilizing filter and a first port so constructed and arranged that the fluid enters the port and flows through the filter and into the interior of the container; and a source of sterile water including means for establishing fluid communication between the source of sterile water and the port. 12. The system of claim 11 wherein the solute is a powder. 13. The system of claim 11 wherein the solute is a liquid concentrate. 14. The system of claim 11 wherein the solute includes a component chosen from the group consisting of: dextrose; sodium chloride; and lactated Ringer's. 15. The system of claim 11 wherein the parenteral solution created is chosen from the group consisting of: saline; dextrose; and lactated Ringer's. 16. The system of claim 11 wherein the means for creating turbulence and the flow path is a seal located within the interior of the container. 17. The system of claim 11 wherein the container includes at least one medication port and an administration port. 18. The system of claim 11 wherein the first port includes a one way valve. 19. The system of claim 11 wherein the first port includes a bidirectional valve. 20. The system of claim 11 wherein the filter is removably coupled to the container. 21. A container for reconstituting a parenteral solution comprising: a flexible body having an interior that is empty prior to adding a fluid except for a prepackaged amount of a solute and a means for creating turbulence wherein the means for creating turbulence forms at least one fluid flow path within the interior, a sterilizing filter coupled to the container and in fluid communication with a first opening in the container allowing the fluid to flow from the filter into the interior of the container, and a port in fluid communication with an end of the sterilizing filter, the container being so constructed and arranged that fluid flow is from the port, through the filter, and into the interior of the container. 22. The container of claim 21 wherein the solute is a powder. 23. The container of claim 21 wherein the solute is a liquid concentrate. 24. The container of claim 21 wherein the solute includes a component chosen from the group consisting of: dextrose; sodium chloride; and lactated Ringer's. 25. The system of claim 21 wherein the means for creating turbulence and a flow path is a seal located within the interior. 26. The container of claim 21 wherein the parenteral solution created is chosen from the group consisting of: saline; dextrose; and lactated Ringer's. 27. The container of claim 21 wherein the container includes at least one medication port and an administration port. 28. The container of claim 21 wherein the port includes a one-way valve. 29. The container of claim 21 wherein the port 10 includes a bidirectional valve. 30. The container of claim 21 wherein the filter is removably coupled to the container. 31. The container of claim 21 wherein the means for creating turbulence and at least one fluid flow path defines two areas within the interior of the container, the solute being located in a first of the two areas. 32. A method for creating parenteral solutions in large volume containers comprising the steps of: providing a flexible container having an interior that is empty prior to adding a fluid except for a prepackaged solute; providing the flexible container with a port outside the container and a sterilizing filter assembly in fluid communication with the interior of the container and the port; coupling the port to a sterile water source; allowing sterile water from the water source to flow through the filter into the interior of the container; and allowing the water to mix with the solute to create a parenteral solution. 33. The method of claim 32 including the step of creating sterile water that is fed into the container from a nonsterile water source approximately contemporaneously with the flow of the water into the container. 34. The method of claim 32 including the step of adding to the resultant parenteral solution a medicament. 35. The method of claim 32 wherein the solute is a powder. 36. The method of claim 32 wherein the solute is a liquid concentrate. 37. The method of claim 32 wherein the solute includes a component chosen from the group consisting of: dextrose; sodium chloride; and lactated Ringer's. 38. The method of claim 32 wherein the parenteral solution created is chosen from the group consisting of: saline; dextrose; and lactated Ringer's. 39. The method of claim 32 including the step of removing the filter from the container after creating the parenteral solution.

Details for Patent 5,484,431

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