Claims for Patent: 5,490,848

Summary for Patent: 5,490,848

Title:	System for creating on site, remote from a sterile environment, parenteral solutions
Abstract:	The present invention provides a system and method for creating on site, remote from a sterile environment, parenteral solutions in large volume parenteral containers for intravenous administration to a patient. In an embodiment, this system comprises an empty large volume container including at least one port for accessing an interior of the container. The port includes a sterilizing filter for sterilizing a fluid fed through the port into the container. A second container is provided including a solute and having means for coupling the second container to the large volume container and thereby providing fluid communication therebetween allowing the solute to be received within the interior of the container. A sterile water source is also provided including means for placing the sterile water source in fluid communication with the port and allowing water to flow from the sterile water source into the interior of the container. This allows the solute, and sterile water that has been fed through the filter, to create a parenteral solution in the large volume parenteral container.
Inventor(s):	Finley; Mike (Park City, IL), Scharf; Mike (McHenry, IL), Packard; Jeff (Grayslake, IL), Kipp; Jim (Palatine, IL), Dudar; Tom (Palatine, IL), Owens; Jim (McHenry, IL), Bindokas; Al (Clarendon Hills, IL)
Assignee:	The United States of America as represented by the Administrator of the (Washington, DC)
Application Number:	07/647,113
Patent Claims:	1. A system for creating on site, remote from a sterile environment, parenteral solutions in a large volume parenteral container for intravenous administration to a patient comprising: an empty large volume containers including at least one port for accessing an interior of the container and having a sterilizing filter for sterilizing a fluid fed through the port into the container; a second container including a solute and having means for coupling the second container to the large volume container and providing fluid communication therebetween allowing the solute to be received within the interior of the container; and a sterile water source including means for placing the sterile water source in fluid communication with the port and allowing sterile water to flow from the sterile water source into the interior of the container. 2. The system of claim 1 wherein the solute is in a powder form. 3. The system of claim 1 wherein the solute is in a liquid concentrate form. 4. The system of claim 1 wherein the solute is chosen from the group consisting of: dextrose; sodium chloride; and lactated Ringer's. 5. The system of claim 1 wherein a parenteral solution created is chosen from the group consisting of saline, dextrose, and lactated Ringer's. 6. The system of claim 1 wherein the second container includes a syringe prefilled with solute. 7. The system of claim 1 wherein the second container is so constructed and arranged as to allow sterile water to flow through an interior thereof into the interior of the large volume container. 8. The system of claim 1 wherein the large volume container includes an additive port and an administration port. 9. The system of claim 1 wherein the sterilizing filter is removably secured to the large volume container. 10. A system for creating on site, remote from a sterile environment, parenteral solutions in a large volume parenteral container for intravenous administration to a patient comprising: an empty large volume container including at least two ports for accessing an interior of the container, a first of the two ports including a sterilizing filter for sterilizing a fluid fed through the port into the container; a device housing a solute and including means that cooperate with a second of the two ports to allow the device to be coupled onto the container and fluid communication to be established between the interior of the container and an interior of the device allowing the solute to be injected into the interior of the container; and a sterile water source including means for allowing the sterile water source to be coupled to the first port and fluid communication to be established between the fluid source and an interior of the container. 11. The system of claim 10 wherein the solute is in a powder form. 12. The system of claim 10 wherein the solute is in a liquid concentrate form. 13. The system of claim 10 wherein the solute includes a component chosen from the group consisting of: dextrose; sodium chloride; and lactated Ringer's. 14. The system of claim 10 wherein the device is a syringe. 15. The system of claim 14 wherein the syringe includes a blunt end. 16. The system of claim 14 wherein the syringe includes means for preventing an inadvertent discharge of the contents of the syringe. 17. The system of claim 16 wherein the means includes a removable pin that is received within at least one aperture of a body of the syringe and one aperture in a plunger of the syringe. 18. The system of claim 14 wherein the second port includes means for locking the syringe to the container. 19. The system of claim 10 wherein the container includes an additive port and an administration port. 20. The system of claim 14 wherein the second port includes means for releasably receiving an end of the syringe. 21. The system of claim 10 wherein the second port includes a frangible seal that is so constructed and arranged that it ruptures to allow solute to be injected into the container. 22. The system of claim 10 wherein the second port includes a one way valve. 23. The system of claim 10 wherein the first port includes a bidirectional valve. 24. The system of claim 10 wherein the sterilizing filter is removably secured to the container. 25. A system for creating on site, remote from a sterile environment, parenteral solutions in a large volume, parenteral container for intravenous administration to a patient comprising: an empty large volume parenteral container having a plurality of ports including at least one port for accessing an interior of the container, the port including a sterilizing filter for sterilizing a fluid fed through the port into the container; a second container housing a solute in an interior thereof and having a first coupling member for coupling the second container to the port and establishing fluid communication between the interior of the second container and the interior of the large volume parenteral container and a second coupling member; and a sterile water source for providing sterile water and including a coupling member for coupling the sterile water source to the second coupling member of the second container and establishing fluid communication from the sterile water source and the interior of the second container. 26. The system of claim 25 wherein the solute is in a powder form. 27. The system of claim 25 wherein the solute is in a liquid concentrate form. 28. The system of claim 25 wherein the solute includes a component chosen from the group consisting of: dextrose; sodium chloride; and lactated Ringer's. 29. The system of claim 25 wherein the second container includes in an interior thereof channels. 30. The system of claim 25 wherein the second container includes an interior that defines a circular fluid flow path. 31. The system of claim 25 wherein the second container includes an interior that defines an elongated serpentine fluid flow path. 32. The system of claim 25 wherein the large volume parenteral container includes an additive port and an administration port. 33. The system of claim 25 wherein the port includes a one way valve. 34. The system of claim 25 wherein the port includes a bidirectional valve. 35. The system of claim 25 wherein the sterilizing filter is removably secured to the large volume parenteral container. 36. A method for preparing parenteral solutions on site, remote from a sterile environment, comprising the steps of: providing an empty large volume parenteral container including means for allowing the container to receive a solute and including a sterilizing filter; coupling a device including a solute to the container; causing the solute to enter an interior of the container; feeding sterile water into the container so that it flows through the sterilizing filter before entering the container; and allowing the solute and sterile water to mix and create a parenteral solution. 37. The method of claim 36 comprising the steps of: providing the container with two ports; and causing the solute to enter the interior of the container through one port and the sterile water to enter the container through a second port. 38. The method of claim 36 wherein the sterile water is fed into the second container prior to the solute entering the second container. 39. The method of claim 36 wherein the sterile water enters the second container contemporaneously with the solute. 40. The method of claim 36 wherein the solute is a powder. 41. The method of claim 36 wherein the solute is a liquid concentrate. 42. The method of claim 36 wherein the solute includes a component chosen from the group consisting of dextrose; sodium chloride; and lactated Ringer's. 43. The method of claim 36 including the step of adding a medicament to the parenteral solution. 44. The method of claim 36 wherein the parenteral solution is administered intravenously to the patient. 45. The method of claim 36 wherein the parenteral solution created is chosen from the group consisting of dextrose, saline, and lactated Ringer's. 46. The method of claim 36 including the step of removing the sterilizing filter from the large volume parenteral container after the parenteral solution is created. 47. A method for preparing parenteral solutions on site, remote from a sterile environment, comprising the steps of: providing an empty large volume parenteral container including means for allowing the container to receive a solute and including a sterilizing filter; coupling a device including a solute to the container; causing the solute to enter an interior of the container; feeding sterile water into the container so that it flows through the sterilizing filter; allowing the solute and sterile water to mix and create a parenteral solution; and providing for the device a second container that is coupled to a port and the sterile water source is coupled to an end of the second container so that sterile water is fed into the interior of the second container and the solute and sterile water then flows through the port and the filter into the container.

Details for Patent 5,490,848

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