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An apparatus and method are provided for generating sterile infusion fluid from non-sterile infusion fluid produced by a machine. In one embodiment, the sterile infusion fluid is produced by a sterile fluid generating device that is an ancillary device designed to operate in conjunction with the exi

An apparatus and method are provided for generating sterile infusion fluid from non-sterile infusion fluid produced by a machine. In one embodiment, the sterile infusion fluid is produced by a sterile fluid generating device that is an ancillary device designed to operate in conjunction with the existing machine. For example, the sterile fluid generating device is used in conjunction with a dialysis machine according to one embodiment resulting in sterile infusion fluid being produced.

대표청구항 ▼

What is claimed is: 1. A system for generating a sterile infusion fluid comprising: a machine for producing non-sterile infusion fluid, the machine having an outflow line for discharging the non-sterile infusion fluid from the machine and a return line for receiving a fluid, the outflow line includ

What is claimed is: 1. A system for generating a sterile infusion fluid comprising: a machine for producing non-sterile infusion fluid, the machine having an outflow line for discharging the non-sterile infusion fluid from the machine and a return line for receiving a fluid, the outflow line including an outlet connector and the return line including a return connector; a first conduit having first and second ends with a first connector at the first end for mating with the outlet connector and a second connector at the second end for mating with the return connector, the first conduit having a third connector permitting at least a portion of the non-sterile infusion fluid to be diverted from the first conduit under select conditions, the first conduit further including a first valve disposed between the third connector and the second connector; a second conduit connected at one end to the third connector, the second conduit being connected at an opposite end to a filtration assembly including at least one sterilization filter for sterilizing the diverted non-sterile infusion fluid; and a device for increasing fluid pressure within the first conduit at a location downstream of the first valve so as to cause a fluid pressure increase in the return and outflow lines resulting in at least a portion of the non-sterile infusion fluid being diverted from the first conduit and into the second conduit wherein the first valve comprises a check valve configured to permit fluid flow in a direction from the first end of the first conduit toward the second end of the first conduit. 2. The system of claim 1, wherein the machine is a dialysis machine and the non-sterile infusion fluid is a non-sterile dialysate fluid. 3. The system of claim 1, wherein the fluid received in the return line includes the non-sterile infusion fluid. 4. The system of claim 1, wherein the device for increasing fluid pressure includes a source of second fluid and a third conduit which is fluidly connected at one end to the source and is connected at an opposite end to the first conduit at the location downstream of the first valve, the device injecting the second fluid under pressure into the first conduit at the downstream location. 5. The system of claim 4, further including a fourth connector at the downstream location, the fourth connector receiving the pressurized second fluid which is injected into the non-sterile infusion fluid flowing through the first conduit. 6. The system of claim 4, wherein the second fluid is water. 7. The system of claim 4, wherein the second fluid is water and the second fluid source is the same fluid source that supplies water to a proportioning system or the machine, the proportioning system mixing the water with infusion concentrate at a predetermined proportion to produce non-sterile infusion fluid of a predetermined concentration. 8. The system of claim 4, further including a pressure regulator disposed within the third conduit for regulating the downstream fluid pressure of the second fluid flowing within the third conduit, thereby also regulating the rate of injection of the second fluid into the first conduit and the pressure increase observed in the first conduit. 9. The system of claim 8, wherein the fluid pressure within the third conduit is from about 2 psi to about 10 psi. 10. The system of claim 4, wherein the second fluid is of a type that is both miscible with the non-sterile infusion fluid and compatible with any materials that are present in any flow path communicating with the machine, including the return line. 11. The system of claim 1, wherein the filtration assembly includes two sterilization filters connected in series to provide redundant sterilization of the infusion fluid. 12. The system of claim 1, further including a device for storing the sterilized infusion fluid. 13. The system of claim 12, wherein the storage device comprises at least one sterile collection bag which is in fluid communication with an outlet port of the at least one sterilization filter. 14. The system of claim 1, further including a fluid reservoir containing a second fluid and wherein the device for increasing fluid pressure includes a reservoir outflow conduit in fluid communication with the fluid reservoir at one end, the reservoir outflow conduit being connected at an opposite end thereof to the first conduit at the location downstream of the first valve, a pump being provided for drawing the second fluid from the fluid reservoir and through the reservoir outflow conduit and into the first conduit under pressure, the device further including a reservoir inflow conduit for receiving fluid flowing within the first conduit, the reservoir inflow conduit being fluidly connected to the first conduit, a back pressure regulator being provided in the reservoir inflow conduit for generating a back pressure, thereby causing the fluid pressure increase in the first conduit, the return line, and the outflow line. 15. The system of claim 1, wherein the device for increasing fluid pressure includes a fluid reservoir holding a second fluid, a pump for withdrawing the second fluid from the fluid reservoir through a pump inlet line and delivering the second fluid under pressure through a pump outlet line to the downstream location of the first valve, and a back pressure regulator being provided in a pump recirculating line that is in fluid communication with the fluid in the pump inlet line and the pump outlet line, thereby causing the fluid pressure increase in the first conduit, the return line, and the outflow line. 16. The system of claim 14, further including a drain conduit for discharging unwanted fluid from the machine, the drain conduit being in fluid communication with the fluid reservoir such that the second fluid comprises the unwanted fluid that has been discharged from the machine. 17. The system of claim 1, further including a control unit, the control unit including a flow sensor device located in the first conduit for monitoring the flow properties of the non-sterile infusion fluid. 18. The system of claim 17, further including a second valve disposed in the second conduit and being in communication with the control unit, the control unit signaling the second valve to close when the sensor detects that the non-sterile infusion fluid is no longer flowing through the first conduit the second valve being reopened once the sensor detects flow of the non-sterile infusion fluid through the first conduit. 19. The system of claim 17 further including a device for storing the sterilized infusion fluid, the control unit including a sensor associated with the storage device for detecting when a predetermined amount of the sterilized infusion fluid is present in the storage device, the control unit being in communication with a third valve disposed in a conduit connecting the filtration assembly to the storage device, the control unit signaling the third valve to close once the predetermined amount is achieved. 20. The system of claim 1, wherein the machine includes a flow balancing mechanism for regulating flow rate of the non-sterile fluid being produced by the machine and regulating the flow rate of the fluid being returned to the machine through the return line. 21. A system of claim 13, further including a rinse collection bag that is filled prior to the filing of the sterile collection bag, the rinse collection bag being in fluid communication through a collection conduit with an outlet port of the at least one sterilizing filter, a valve being disposed within the collection conduit so that once the rinse collection bag is filled to a predetermined level, the sterile infusion fluid is diverted to the sterile collection bag. 22. A method of generating a sterile infusion fluid, the method comprising: producing non-sterile infusion fluid with a machine having an outflow line for discharging the non-sterile infusion fluid from the machine and a return line for receiving a fluid; connecting a first conduit between the outflow line and the return line, the first conduit having a first connector permitting at least a portion of the non-sterile infusion fluid to be diverted from the first conduit under select conditions, the first conduit including a valve located downstream of the first connector, the valve permitting fluid within the first conduit to flow only in a direction from the outflow line towards the return line; connecting a second conduit at one end to the first connector, the second conduit being connected at an opposite end to a filtration assembly including at least one sterilization filter for sterilizing the diverted non-sterile infusion fluid; discharging the non-sterile infusion fluid through the outflow line; and increasing the fluid pressure within the first conduit at a location downstream of the valve so as to cause a fluid pressure increase in each of the first conduit, the return line, and the outflow line resulting in the at least a portion of the non-sterile infusion fluid being diverted from the first conduit and into the second conduit through which the non-sterile infusion fluid flows to the filtration assembly. 23. The method of claim 22, wherein increasing the fluid pressure comprises: injecting a second fluid under pressure through a third conduit into the first conduit at the location downstream of the valve so as to cause the fluid pressure increase. 24. The method of claim 23, wherein the degree of pressure of which the second fluid is injected into the first conduit is adjusted by a pressure regulator in the third conduit. 25. The method of claim 23, wherein the second fluid is from the same fluid source that is supplied to the machine for preparing the non-sterile infusion fluid. 26. The method of claim 23, wherein injecting the second fluid comprises: pumping the second fluid through a third conduit from a fluid reservoir and into the first conduit at the location downstream of the valve and increasing the fluid pressure further includes setting a back pressure regulator to generate a back pressure in a fourth conduit that is in fluid communication with the first conduit. 27. The method of claim 26, wherein the second fluid comprises waste fluid that is discharged from the machine to the fluid reservoir, a drain run-off outlet being provided with the fluid reservoir for discharging excess second fluid from the fluid reservoir.