Claims for Patent: 8,518,252

Summary for Patent: 8,518,252

Title:	System for field intravenous fluid reconstruction
Abstract:	The present invention provides a new and improved system for on-site and on-demand production of sterile water for injection (SWFI) from potable water or water that meets the EPA drinking water quality upon preconditioning, in conjunction with reconstitution of IV fluids using dry chemicals or concentrate pre-filled bags, suitable for use at a site under non-clean room environment conditions, and capable of adjusting feed water temperatures. The present invention includes a water temperature conditioning module, a water preconditioning module, a hydrothermal processor, a fluid staging compartment, and combinations and variations thereof.
Inventor(s):	Li; Lixiong (Panama City, FL)
Assignee:	Applied Research Associates, Inc. (Albuquerque, NM)
Application Number:	12/119,480
Patent Claims:	1. A system to produce sterile water for injection (SWFI) for on-site and on-demand intravenous fluid reconstitution, from feed water, comprising: a) a water preconditioning module comprising a pre-filter, a primary pump, reverse osmosis membranes, de-ionization resin beds, and first and second flow restrictors, wherein the water preconditioning module is designed and configured so that (i) the reverse osmosis membrane partitions the filtered water into a filtrate and a retentate, and passes the filtrate along a flow-path to and through the de-ionization resin beds to form de-ionized filtrate, while removing the retentate from this flow-path; (ii) the first flow restrictor controls the amount of retentate which is drawn back to the prefilter for recirculation through the water preconditioning module; and (iii) the second flow restrictor controls the amount of retentate which is expelled from the module; b) a hydrothermal processor module comprising a first heat exchanger, a reactor coupled with a heater, a flow restrictor and a plurality of valves, wherein the hydrothermal processor module is designed and configured so that (i) the coupled reactor and heater sterilize and depyrogenate the de-ionized filtrate; (ii) the first heat exchanger transfers heat from SWFI to the de-ionized filtrate; (iii) at least one of the valves diverts steam generated during the sterilization and depyrogenation of the de-ionized filtrate and away from the hydrothermal processor module; and (iv) at least one of the other valves diverts SWFI from the hydrothermal processor module; and c) a fluid staging compartment comprising a surge tank, a conductivity sensor in said surge tank, a recirculation pump, and a drain valve, wherein the fluid staging compartment is designed and configured so that (i) the surge tank receives retentate being expelled from the water preconditioning module, steam from the hydrothermal processor module, and diverted SWFI from the hydrothermal processor module; and (ii) the conductivity sensor measures the quality of the retentate, and based upon such measurement the drain valve allows continuous or intermittent draining of at least a portion of the accumulated water in the surge tank from the system; and (c) or the recirculation pump recirculates at least some of the water from the surge tank back to the water preconditioning module. 2. The system of claim 1, wherein the surge tank of the fluid staging compartment further comprises means to receive bottled water. 3. The system of claim 1, wherein the surge tank of the fluid staging compartment further comprises one or more sensors that can detect conditions of water within the surge tank, the sensors being selected to measure conditions of water within the tank, such conditions being selected from the group consisting of: temperature and pressure and conductivity. 4. The system of claim 1, further comprising means to cool the temperature of the feed water to within a pre-determined temperature range prior to drawing the water into the water preconditioning module, wherein the cooling means comprises a heat exchanger, a radiator and a fan, wherein the fan is designed and configured to force ambient air through said radiator. 5. The system of claim 4, further comprising a container designed and configured to house the heat exchanger, and a water jet vacuum pump, wherein the cooling means is designed and configured to transfer the feed water through the radiator, and then transfer a first portion of the feed water to the heat exchanger, and a second portion of the feed water to the container; and wherein the water jet is coupled with the container so that the water jet, when in operation, reduces the pressure within the container. 6. The system of claim 1, further comprising means to cool the temperature of the feed water to within a pre-determined temperature range prior to drawing the water into the water preconditioning module, wherein the cooling means comprises a refrigeration device having a heat transfer fluid, a heat exchanger and a container, and is designed and configured so that the refrigeration device cools the heat transfer fluid, the container houses the heat exchanger and receives the cooled heat transfer fluid, and the feed water is transmitted through and cooled by means of the heat exchanger. 7. The system of claim 1, further comprising means to cool the temperature of the feed water to within a pre-determined temperature range prior to drawing the water into the water preconditioning module, wherein the cooling means comprises a refrigeration device having cooling surfaces, wherein the module is designed and configured so that at least a portion of the feed water is in contact with said cooling surfaces. 8. The system of claim 1, further comprising means to cool the temperature of the feed water to within a pre-determined temperature range, wherein the cooling means comprises a refrigeration device, a heat transfer fluid and a jacketed vessel having an interior cavity between two surfaces, wherein the cooling means is designed and configured so that the vessel receives cooled heat transfer fluid from the refrigeration device, and the feed water is circulated through the vessel interior cavity. 9. The system of claim 1, further comprising means to heat the temperature of the feed water to within a pre-determined temperature range prior to drawing the water into the water preconditioning module, said means comprising a thermostatic mixing valve, a heater and a plurality of valves; wherein the heating means is designed and configured so that a first valve controls the amount of water transferred to the heater, a second valve controls the amount of water diverted around the heater, and the thermostatic mixing valve receives heated water and diverted water, and controls the amount of water from each so that water delivered from the thermostatic mixing valve is within a pre-determined temperature range. 10. The system of claim 1, further comprising means to heat the temperature of the feed water to within a pre-determined temperature range prior to drawing the water into the water preconditioning module, said means comprising a heat exchanger, wherein the heat exchanger is designed and configured to exchange heat from the deionized filtrate to the feed water. 11. The system of claim 1, wherein the hydrothermal processor module further comprises a second heat exchanger in series with the first heat exchanger, and a thermostatic mixing valve, and wherein the module is designed and configured to adjust the temperature of the SWFI by drawing a portion of the SWFI from the first heat exchanger, and a portion from the second heat exchanger, and delivering the SWFI from each heat exchanger to the thermostatic mixing valve. 12. The system of claim 11, wherein the hydrothermal processor module further comprises a radiator coupled with a fan, in series with the thermostatic mixing valve, wherein the radiator is designed and configured to cool the SWFI passing from one of the heat exchangers. 13. The system of claim 1, wherein the hydrothermal processor module further comprises a secondary pump in series with the first heat exchanger. 14. The system of claim 1, wherein the fluid staging compartment further comprises a refrigeration device adapted and configured to receive and cool at least a portion of the feed water, and deliver the cooled feed water to the surge tank. 15. A system to produce sterile water for injection (SWFI) for on-site and on-demand intravenous fluid reconstitution, from feed water, comprising: a) means to cool the temperature of the feed water to within a pre-determined temperature range, wherein the cooling means comprises a heat exchanger, a radiator and a fan, wherein the fan is designed and configured to force ambient air through said radiator; b) a water preconditioning module comprising a pre-filter, a primary pump, reverse osmosis membranes, de-ionization resin beds, and first and second flow restrictors, wherein the water preconditioning module is designed and configured so that (i) the reverse osmosis membrane partitions the filtered water into a filtrate and a retentate, and passes the filtrate along a flow-path to and through the de-ionization resin beds to form de-ionized filtrate, while removing the retentate from this flow-path; (ii) the first flow restrictor controls the amount of retentate which is drawn back to the prefilter for recirculation through the water preconditioning module; and (iii) the second flow restrictor controls the amount of retentate which is expelled from the module; c) a hydrothermal processor module comprising a first heat exchanger, a reactor coupled with a heater, a flow restrictor and a plurality of valves, wherein the hydrothermal processor module is designed and configured so that (i) the coupled reactor and heater sterilize and depyrogenate the de-ionized filtrate; (ii) the first heat exchanger transfers heat from SWFI to the de-ionized filtrate; (iii) at least one of the valves diverts SWFI from the hydrothermal processor module; and d) a fluid staging compartment comprising a surge tank, a conductivity sensor in said surge tank, a recirculation pump, and a drain valve, wherein the fluid staging compartment is designed and configured so that (i) the surge tank receives retentate being expelled from the water preconditioning module and diverted SWFI from the hydrothermal processor module; and (ii) the conductivity sensor measures the quality of the retentate, and based upon such measurement the drain valve allows continuous or intermittent draining of at least a portion of the accumulated water in the surge tank from the system; and (c) or the recirculation pump recirculates at least some of the water from the surge tank back to the water preconditioning module. 16. The system of claim 15, wherein the cooling means further comprises a container designed and configured to house the heat exchanger, and a water jet vacuum pump, wherein the cooling means is designed and configured to transfer the feed water through the radiator, and then transfer a first portion of the feed water to the heat exchanger, and a second portion of the feed water to the container; and wherein the water jet is coupled with the container so that the water jet, when in operation, reduces the pressure within the container. 17. The system of claim 15, wherein the hydrothermal processor module further comprises a second heat exchanger in series with the first heat exchanger, a thermostatic mixing valve, and a radiator and a fan, wherein the module is designed and configured to adjust the temperature of the SWFI by drawing a portion of the SWFI from the first heat exchanger, and the remainder of the SWFI from the second heat exchanger, passing the portion of SWFI from the second heat exchanger through the radiator, and delivering the SWFI from the first heat exchanger and the radiator to the thermostatic mixing valve. 18. A system to produce sterile water for injection (SWFI) for on-site and on-demand intravenous fluid reconstitution, from feed water, comprising: a) means to cool the temperature of the feed water to within a pre-determined temperature range, wherein the cooling means comprises a refrigeration device and a container; b) a water preconditioning module comprising a pre-filter, a primary pump, reverse osmosis membranes, de-ionization resin beds, and first and second flow restrictors, wherein the water preconditioning module is designed and configured so that (i) the reverse osmosis membrane partitions the filtered water into a filtrate and a retentate, and passes the filtrate along a flow-path to and through the de-ionization resin beds to form de-ionized filtrate, while removing the retentate from this flow-path; (ii) the first flow restrictor controls the amount of retentate which is drawn back to the prefilter for recirculation through the water preconditioning module; and (iii) the second flow restrictor controls the amount of retentate which is expelled from the module; c) a hydrothermal processor module comprising a first heat exchanger, a reactor coupled with a heater, a flow restrictor and a plurality of valves, wherein the hydrothermal processor module is designed and configured so that (i) the coupled reactor and heater sterilize and depyrogenate the de-ionized filtrate; (ii) the first heat exchanger transfers heat from SWFI to the de-ionized filtrate; (iii) at least one of the valves diverts SWFI from the hydrothermal processor module; and d) a fluid staging compartment comprising a surge tank, a conductivity sensor in said surge tank, a recirculation pump, and a drain valve, the surge tank comprises means to directly receive water from a standard personal water container, wherein the fluid staging compartment is designed and configured so that (i) the surge tank receives retentate being expelled from the water preconditioning module and diverted SWFI from the hydrothermal processor module; and (ii) the conductivity sensor measures the quality of the retentate, and based upon such measurement the drain valve allows continuous or intermittent draining of at least a portion of the accumulated water in the surge tank from the system; and (iii) or the recirculation pump recirculates at least some of the water from the surge tank back to the water preconditioning module. 19. The system of claim 18, wherein the cooling means further comprises two heat exchangers, a heat transfer fluid, a refrigerant, and a recirculation pump, wherein the first heat exchanger uses the refrigerant, and the second heat exchanger uses the heat transfer fluid, and further wherein the feed water is fed through the second heat exchanger, and transfers heat from the feed water to the heat transfer fluid; the recirculation pump circulates the heat transfer fluid to the first heat exchanger; and the first heat exchanger transfers heat from the heat transfer fluid to the refrigerant. 20. The system of claim 19, wherein the heat transfer fluid is selected from the group consisting of: water, aqueous salt solutions, organic compounds or solutions, and ionic liquids. 21. The system of claim 18, wherein the container is a jacketed vessel having an interior cavity between two surfaces, wherein the cooling means is designed and configured so that the feed water is circulated through the jacketed vessel interior cavity. 22. The system of claim 18, wherein the refrigeration device includes surfaces in contact with a heat transfer fluid, and wherein the system is designed and configured so that the feed water is cooled by direct contact with the surfaces.

Details for Patent 8,518,252

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		2039-09-22