WO2005068043A1 - Systeme de filtration permettant la preparation de fluides destines a des applications medicales - Google Patents

Systeme de filtration permettant la preparation de fluides destines a des applications medicales Download PDF

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Publication number
WO2005068043A1
WO2005068043A1 PCT/US2005/000381 US2005000381W WO2005068043A1 WO 2005068043 A1 WO2005068043 A1 WO 2005068043A1 US 2005000381 W US2005000381 W US 2005000381W WO 2005068043 A1 WO2005068043 A1 WO 2005068043A1
Authority
WO
WIPO (PCT)
Prior art keywords
controller
fluid
container
filter
water
Prior art date
Application number
PCT/US2005/000381
Other languages
English (en)
Inventor
Jeffrey H. Burbank
Brian C. Green
Dennis M. Treu
Christopher S. Mcdowell
Friederichs Goetz
Original Assignee
Nxstage Medical, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/US2004/000476 external-priority patent/WO2004062710A2/fr
Priority to US10/585,675 priority Critical patent/US20080210606A1/en
Application filed by Nxstage Medical, Inc. filed Critical Nxstage Medical, Inc.
Publication of WO2005068043A1 publication Critical patent/WO2005068043A1/fr
Priority to EP06717769A priority patent/EP1838356B1/fr
Priority to DE602006017654T priority patent/DE602006017654D1/de
Priority to US11/813,472 priority patent/US9700663B2/en
Priority to AT06717769T priority patent/ATE485061T1/de
Priority to JP2007550528A priority patent/JP4734343B2/ja
Priority to CA2593580A priority patent/CA2593580C/fr
Priority to PCT/US2006/000608 priority patent/WO2006074429A1/fr
Priority to US13/083,915 priority patent/US8679348B2/en
Priority to US13/603,505 priority patent/US8545428B2/en
Priority to US13/968,430 priority patent/US9388059B2/en
Priority to US15/195,801 priority patent/US10130746B2/en
Priority to US15/615,655 priority patent/US10420871B2/en
Priority to US16/164,047 priority patent/US11446417B2/en
Priority to US16/185,525 priority patent/US20190076589A1/en
Priority to US16/423,214 priority patent/US10973969B2/en
Priority to US17/212,866 priority patent/US11896750B2/en
Priority to US18/396,765 priority patent/US20240123128A1/en

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/18—Apparatus therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/022—Filtration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/145—Ultrafiltration
    • B01D61/146—Ultrafiltration comprising multiple ultrafiltration steps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/16—Feed pretreatment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/22—Controlling or regulating
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00—Treatment of water, waste water, or sewage
    • C02F1/008—Control or steering systems not provided for elsewhere in subclass C02F
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00—Treatment of water, waste water, or sewage
    • C02F1/30—Treatment of water, waste water, or sewage by irradiation
    • C02F1/32—Treatment of water, waste water, or sewage by irradiation with ultraviolet light
    • C02F1/325—Irradiation devices or lamp constructions
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00—Treatment of water, waste water, or sewage
    • C02F1/44—Treatment of water, waste water, or sewage by dialysis, osmosis or reverse osmosis
    • C02F1/444—Treatment of water, waste water, or sewage by dialysis, osmosis or reverse osmosis by ultrafiltration or microfiltration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2311/00—Details relating to membrane separation process operations and control
    • B01D2311/04—Specific process operations in the feed stream; Feed pretreatment
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00—Treatment of water, waste water, or sewage
    • C02F1/42—Treatment of water, waste water, or sewage by ion-exchange
    • C02F2001/422—Treatment of water, waste water, or sewage by ion-exchange using anionic exchangers
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00—Treatment of water, waste water, or sewage
    • C02F1/42—Treatment of water, waste water, or sewage by ion-exchange
    • C02F2001/425—Treatment of water, waste water, or sewage by ion-exchange using cation exchangers
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F2101/00—Nature of the contaminant
    • C02F2101/10—Inorganic compounds
    • C02F2101/12—Halogens or halogen-containing compounds
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F2101/00—Nature of the contaminant
    • C02F2101/30—Organic compounds
    • C02F2101/36—Organic compounds containing halogen
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F2209/00—Controlling or monitoring parameters in water treatment
    • C02F2209/003—Downstream control, i.e. outlet monitoring, e.g. to check the treating agents, such as halogens or ozone, leaving the process
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F2209/00—Controlling or monitoring parameters in water treatment
    • C02F2209/05—Conductivity or salinity
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F2301/00—General aspects of water treatment
    • C02F2301/08—Multistage treatments, e.g. repetition of the same process step under different conditions
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F2303/00—Specific treatment goals
    • C02F2303/04—Disinfection

Definitions

  • Fig. 1A illustrates a fluid preparation apparatus embodiments in a figurative way for discussing various features and arrangements of a medical fluid purification system.
  • Fig. 1 B illustrates a filter device with control elements that provide assurance of fluid quality and prevent breakthrough of contamination upon filter expiration.
  • Figs. 2A and 2B illustrate a filter and batch container with connector systems that ensure against contamination.
  • Fig. 3 illustrates a self-clamping connector.
  • Fig. 4 illustrates a batch container tubing set.
  • Fig. 5 illustrates a fluid preparation apparatus embodiment in a figurative way for discussing various features and arrangements of a water purification system.
  • Figs. 6, 7, and 8A illustrate portions of an embodiment of a fluid preparation apparatus.
  • FIG. 8B illustrates a portion of a filter module in which two redundant ultrafiltration membranes are commonly housed.
  • Figs. 9A and 9B illustrate embodiments of a batch container.
  • Fig. 10A illustrates a fluid quality sensor such as a conductivity or resistivity sensor configuration for sensing fluid quality in a container.
  • Fig. 10B illustrates a medicament concentrate cartridge.
  • Fig. 11 illustrates a filter module in partial ghost perspective view.
  • Fig. 12 illustrates a filter cartridge with an expansion device.
  • Figs. 13A and 13B illustrate fluid preparation devices for use with a replaceable filter module such as the one illustrated in Fig. 11.
  • Fig. 14 illustrates a control system to support features of various embodiments.
  • Fig. 10A illustrates a fluid quality sensor such as a conductivity or resistivity sensor configuration for sensing fluid quality in a container.
  • Fig. 10B illustrates a medicament concentrate cartridge.
  • Fig. 11 illustrates a filter module in partial ghost perspective view.
  • Fig. 16 illustrates a treatment environment for use of a control embodiment.
  • Figs. 17, 17A, and 18 illustrate ultrafilter configurations that are tolerant of the evolution of air from within the ultrafilter.
  • Fig. 1 A is an overview of a framework that provides benefits, particularly in certain environments.
  • One such environment is renal replacement therapy. Patients must be treated at least twice a week and often daily.
  • a permanent module 920 has certain pretreatment components that may be used repeatedly without replacement and without sterilization and includes filtration and treatment steps that are not unduly inclined to aggravate, or susceptible to, contamination. Examples are illustrated in the further embodiments. This permanent module may be designed to receive variations of water quality.
  • a semi-permanent module 922 provides more than one use, for example a month's worth of uses, but is disposable periodically or upon detection of incipient failure. The permanent module may contain a controller to enforce the proper use and handling of the semi-permanent module since
  • the final stage includes final filtration and/or treatment steps provided in a single-use element 924.
  • the least expensive components may be arranged to guard against sterility failures of the upstream components.
  • the preferred embodiments described herein conform to this model. Variations of the model are possible including fragmenting the intermediate modules into ones used according to other schedules such as one module replaced monthly and another replaced weekly.
  • An example of a semi-permanent element and a control system to safeguard against contamination are shown in Fig. 1 B. Note that the embodiment of Fig.
  • a pump 416 feeds raw water into a filter module 425 via an input line 403.
  • the filter module 425 contains first and second filters 410A and 410B.
  • the first and second filter stages 410A and 410B are deionizing filters.
  • the first and second filter stages 410A and 410B may be accompanied by other types of filters (not shown here but discussed and illustrated elsewhere in the instant specification) in the filter module or externally thereto to perform a complete water treatment.
  • Treated water is supplied to a batch container 417, which may or may not be present.
  • water is treated for preparation of a medicament which may be included in concentrate form in the batch container 417 as a presterilized consumable unit.
  • a water quality sensor 405 is provided between the first and second filter stages 410A and 410B.
  • the water quality sensor 405 is a conductivity or resistivity probe that detects ionic species in the water after passing through the first stage filter 410A.
  • the second stage 410B provides at least some redundancy in that the second stage 410B provides some of the filtration effect of the first stage 410A. In an alternative embodiment it provides all of the filtration of the first stage 410A and is thereby completely redundant.
  • the first stage would expire (become depleted), allowing contaminants to break through, before the second stage expires.
  • the contaminant breakthrough is detected by a controller 415 connected to the water quality sensor 405.
  • the controller 415 also controls the pump 416.
  • the controller Upon expiration of the first stage 410A, the controller allows the preparation to continue until a certain amount of fluid is collected in batch container 417, preferably an amount required for a treatment. Once this threshold quantity is delivered, the controller will not allow the pump 416 to be started until the filter module 425 is exchanged with a fresh one.
  • the second stage filter 410B preferably, is sized to ensure that, by itself, it can purify at least a single batch of water, plus a safety margin without any contaminant breakthrough to the output line 404.
  • the second stage filter 410B is a smaller size than the first 410A.
  • the second stage filter 410B may be of a different type which may not be as able to handle high contamination loads as the first 410A. This may be acceptable because, although after breakthrough is detected, the emerging fluid is still substantially purified and the load input to the second stage filter 410B may remain low until a single batch of fluid is prepared.
  • the filter module 425 is provided with a permanently attached data carrier 423 such as radio frequency identification device (RFID), bar code (1- or 2-dimensional), contact-type identification device, etc.
  • RFID radio frequency identification device
  • the data carrier 423 contains a unique identifier of the filter module.
  • the controller 415 reads the data carrier 423 using a reader device 422 and stores the identifier in a memory 437. If the water quality sensor 405 indicates contaminant breakthrough, the controller permanently stores the identifier in an expired directory in the memory, which has a non-volatile portion for the directory.
  • a user attempts to connect a module 425 with an identifier stored in the directory, the controller will not operate the pump and will indicate the error condition by means of an annunciator 420 or equivalent device, such as an LCD display message.
  • the data carrier 423 is a programmable device with a writable memory.
  • the controller 415 programs the data carrier 423 with a flag indicating that the filter module 425 is expired. The controller 415 then prevents the initiation of a new batch.
  • Fig. 1 B also illustrates an optional embodiment with a pressure transducer 435 that may be used to test for clogging of the first stage filter 410A.
  • the controller activates a normally- closed valve 426 to bypass the first filter stage 410A. Water flows through a bypass line 427 and through the second stage filter 410B.
  • the expiration of the filter module 425 may then be enforced by the controller in either of the ways described above.
  • the above embodiment may be used in filter modules 425 that contain filters that clog when depleted such as carbon filters or porous membrane filters. Not that the clogging and breakthrough devices described above may be combined or used exclusively in a given filter module embodiment.
  • the head pressure may be sampled and stored over a period of time to determine if the pressure change profile is characteristic of a filter suffering normal usage.
  • a multi-use filter device 440 has an outlet port 441 A with a cap 444A to avoid contamination.
  • the outlet port 441 A is connectable to a mating port 441 B, which is also capped (cap 444B).
  • the ports 441 A and 441 B may be, for example, locking luer connectors.
  • a special clamping connector 442, which seals itself when disconnected from a mating connector 452 is connected to port 441 B and a line connecting it to a batch container 450 which receives purified water from the multi-use filter device 440.
  • a microporous filter 453 guards against the introduction of contaminants by touch contamination when connectors 441 A and 441 B are mated.
  • the special clamping connector 442 may any suitable device that seals off, to prevent contamination.
  • An embodiment of such a connector is shown in Fig. 3, although the sealing and disconnecting functions, to be described below, can be performed by separate mechanisms so this embodiment is not essential.
  • An outlet tube 460 connectable to the filter 453 of Fig. 2A is permanently affixed to a male luer fitting 478 of a male connector 452 that is received by a female luer fitting 479 of a female connector 442.
  • the female connector 442 has a pair of latch arms 464 that engage a ridge 469 of the male connector 452.
  • the latch arms 464 pivot on living hinges 468 affixed to the female luer fitting 479. Pinching ridges 470 and 476 compress the tube 474 when a bendable retaining ring 472 is squeezed. At the same time, engaging ends 466 of the latch arms 464 retract from the ridge 469 releasing the male luer connector 452.
  • the bendable retaining ring 472 retains its deformed shape once it is pinched so that the tube 474 remains pinched and thereby sealed when the connectors 442 and 452 are disconnected.
  • the bendable retaining ring 472 may be made of ductile metal, for example.
  • the retaining ring 472 may be replaced by another suitable device such as a ratchet mechanism.
  • the multi-use filter device 440 when the multi-use filter device 440 is first used, its outlet connector 441 A is sealed with a cap 444A as is the inlet connector 442 (with cap 444B) of the batch container 450.
  • the batch container 450 may be sealed and sterilized with the special fitting 442 and its mating connector 452, which may correspond to elements 442 and 452 in Fig. 3, connected in a completely sealed and pre-sterilized state.
  • Other ports such as a sampling port 454 may also be sealed and, if only used as outlets, protected from intrusion of fluid by means of a check valve 456 and/or another membrane filter 453 (not shown separately).
  • the caps 444A and 444B are removed and the connectors 441 A and 441 B mated.
  • the special clamping connector 442 is disconnected and left connected to the multi-use filter device 440 to keep it sealed and free from contamination as shown in Fig. 2B.
  • the special clamping connector 442 is removed by means of the connector pair 441 A and 441 B and discarded while a new batch container's 450 connector 441 B is mated to the pre-existing multi-use filter device's 440 outlet connector 441 A.
  • the connector 441 B carries a new special clamping connector 442 and the same process can be repeated.
  • Fig. 4 shows an embodiment of a batch container, for example one that may be used with the foregoing embodiments, but in particular, with the above embodiments.
  • the batch container 1 has a batch container, proper, 1 , a break-off female luer lock connector 4, a y-connector, 5, a pinch clamp 6, a male luer 8, a female luer 26, a sterile filter (e.g., 0.22 micron pore or pyrogen filter) 11 , a non reopenable tubing clamp 13, a non-breathing cap 14 on a female luer 9.
  • a break-off female luer lock connector 4 4, a y-connector, 5, a pinch clamp 6, a male luer 8, a female luer 26, a sterile filter (e.g., 0.22 micron pore or pyrogen filter) 11 , a non reopenable tub
  • Line 15 has an in-line check valve 16, a pinch clamp 18, a break-off male luer cap 25 and female luer 19, and a female luer 21.
  • Various tubing branches 3, 7, 10, 12, 15, 17, and 20 connect these elements.
  • the batch container 1 is delivered to a patient treatment setting as a sealed sterile container with all terminals sealed.
  • the batch container 1 may contain, as delivered, a concentrate solution sufficient to create a treatment batch of fluid, such as5 dialysate or replacement fluid, when water is added. Concentrate may be added by means of the luer connector 21.
  • the tubing branch 20 may be sealed and cut after the concentrate is added. Water is added at the treatment site through connection to a water source via luer 9.
  • the water is preferably metered to provide a predefined quantity.
  • the o sterile filters should be sufficient to protect against contamination by pyrogens before water is added to the batch container 1.
  • a sample of diluted treatment fluid may be drawn through the luer 19 before treatment.
  • the check valve 16 prevents any contamination due to backflow from the sampling procedure.
  • the luer 9 is disconnected from the male luer 8 and the male luer connector connected to the blood treatment system. Luer connectors are shown by way of example as are other features and these are not essential to all embodiments.
  • Fig. 5 illustrates another arrangement of a particular embodiment whose description follows.
  • a pretreatment module 900 provides primary filtration from a raw water supply, for example tap water and feeds prefiltered water to a controller module 905 which provides various control functions, a pump, pressure detection and control, and permanent filtering capabilities which are not shown separately here. Water is metered by the control module into a consumable disposable module 910 which may provide deionization, adsorption filtration, microporous filtering, chemical pretreatment, etc. and any other types of filtering that may require replacement of components. The purified water is finally conveyed to the batch container circuit 915 discussed with reference to Fig. 4. Referring to Fig. 6, pretreatment module 900 is shown in more detail. A check valve 955 prevents backflow.
  • An air vent 953 removes air from the primary supply and a sediment filter 951 (which may be replaceable) provides substantial filtering of solids.
  • the control module 905 is shown in greater detail.
  • a shutoff valve 1010 is provided for safety.
  • Pressure indicators 1015 and 1025 may be provided for monitoring the respective pressures in and out of a pump 1020. Feedback regulation may be provided to ensure that consistent metering is provided if the pump is relied upon for measuring the total quantity of water supplied to the batch container 1.
  • a high intensity ultraviolet (UV) lamp 1031 provides a both sterilization mechanism and a mechanism for removing chlorine and chloramines.
  • the UV lamp 1030 is of such intensity and wavelength as to provide disintegration of chloramines.
  • the lamp is characterized by a 245 nm wavelength and an output power of 750 mJ/cm 2 up to 1500 mJ/cm 2 which is sufficient to remove chloramines.
  • pressure indicators 1015 and 1025 may be pressure transducers that feed control signals to a control device such as discussed with reference to Fig. 1 B and to be discussed with reference to Figs. 13A and 13B.
  • the operation of pump 1020 may be controlled in dependence on pressure indications from such transducers. For example, if a high head pressure is indicated, an alarm may be indicated and the pump shut down.
  • the pump may be operated for a short interval and a pressure decay profile recorded and compared with an expected decay profile. If the profile does not match, it could be used to indicate a leak (such as in a filter or line) or a clog in the system. If the upstream pressure goes low, it could mean that the water supply is turned off or some other fault.
  • Each of these events may be indicated by means of an annunciator or display (e.g., see 330 and 380 at Figs. 13A and 13B and attending discussion) and/or by switching off the pump to avoid damage to the system and to notify the operator to take corrective action. Referring to Fig.
  • the replaceable (disposable or remanufacturable) filter module 910 contains a first stage filter 1007 copper-zinc alloy which is used to subject the water to a reduction/oxidation process to remove ions. This removes ions through a chemical reaction.
  • An embodiment is KDF 85 media where about one pound is used for a flow rate of 150 ml./min water flow rate.
  • a activated carbon filter 1005 follows which is a well-known adsorption type filter.
  • the SAC/SBA filter cartridges 1011/1009 are not mixed beds as typically used in water filtration applications.
  • the order of the SCA and SBA beds is not limited to what is shown and that they can be housed in a single canister or multiple canisters. Also note that other components can be sequenced differently as well as should be clear from this disclosure. For example, it should be clear that the pump 1020 can be used in a pushing arrangement to draw water through the UV lamp and the particulars of the arrangement are not limiting to the inventions disclosed. Also note that the resistivity probe 1022 can be included within a single deionizing filter between previous and following deionization stages and employed to similar effect.
  • a deionizing filter would have leads or contacts to connect the probe to an external measurement device or controller.
  • the resistivity probe 1022 detects ion concentration by contact testing of the resistivity of the water. A signal is generated to indicate that this will be the last allowed batch before the system will require the replacement of the replaceable module 910. Control may be provided as in the embodiment of Fig. 1B, discussed above.
  • the second filter in the present embodiment which backs up the first stage suffering from breakthrough, is a mixed bed deionization filter 1031.
  • TP is a hydrophobic membrane air vent which allows air in ultrafilters 1035A and 1035B to be purged.
  • the ultrafilters 1035A and 1035B may be a microtubular filter such as used for dialysis.
  • An air vent may also be provided as shown at 1047. The air vent may, for example,
  • the second stage MBDI type filter 1031 can be a layered deionization filter such as 1002C with the same benefits as described in terms of providing protection against breakthrough.
  • the final resistivity sensor 1025 can be located as shown or moved to another location downstream of the final deionization stage, such as after or between the ultrafilters 1035A and 1035B, and the configuration shown is not limiting of the invention. Note, it should be clear that resistivity probe 1022 may be used in a configuration such as that of Fig.
  • a multilayer filter with various types of filter elements housed in a common cartridge 1052 contains two ultrafilter layers 1050A and 1050B.
  • the cartridge may be as described in US Patent Publication No. 2004/0105435, which is hereby incorporated by reference as if fully set forth in its entirety herein.
  • the two ultrafilter layers 1050A and 1050B, separate membranes, are kept apart my an intermediate layer 1056, which may be a spacer or another filter medium. Separate seals 1057A and 1057B, which are also spaced apart, are provided.
  • the final conductivity/resistivity sensor/alarm 1025 may control the pump, as noted.
  • a controller 1090 may be connectable to the disposable filter module 910 and configured to stop the pump 1020.
  • the trigger resistivity safety level to cut-off the pump 1020 may be 1 megohm, but may be raised to 2 megohm to allow the use of required temperature compensated resistivity probes (an FDA & AAMI requirement) This does allow use of low cost in-line resistivity probes in the disposable filter module 910.
  • the filter module 910 as well as the modules of other embodiments are of such a flow rate that upward flow of fluids is possible.
  • prior art deionization beds suffer from the problem of floating or loosening resin particles which may have been disturbed during handling.
  • filter systems are configured to direct flow downwardly through the beds to help keep and compress the resin particles. But if flow rates are kept low, as may be done in the present system, water may be flowed in an upward direction which helps to eliminate air from stream. Air is a notorious problem in the preparation of medicaments such as dialysate. The precise flow rates needed to allow upward flow will vary according to the characteristics of the system.
  • One way to allow faster flow rates without being hampered by break away resin particles is to provide a bed compressor of resilient porous material to compress the bed. Referring momentarily to Fig.
  • a resilient compression layer 1140 urges the filtration material 1145 in a downward direction.
  • the resilient compression layer may be any suitable polymeric or rubberlike material that is compatible with the application. The following is an example procedure for using the devices discussed with reference to Fig. 4. 1. Remove the dialysate concentrate tubing set 915 and remove the cap 14 from the tubing line 7 that contains the filter 11. (The 0.22 micron filter 11 provides additional protection from inadvertent contamination.) 2. Connect the outlet line 404 to the concentrate bag luer connection 9. 3. Break the frangible luer connector 4 which connector is configured to form a permanent seal on the side facing the Y-junction 5 when disconnected. 4.
  • Nominal conductivity for the dialysate solution is 13.7 mS/cm at 25°C. If conductivity does not meet this specification do not use it. Verify that the results are accurate. If conductivity is high additional water may be added to bring it within specification. If conductivity is low then the solution must be discarded. 9. Using the non re-opening clamp 13 provided, clamp the line that is connected to the water purification plant. 10. The clamp 6 is, next, clamped on the line that is connected to the dialysate bag 1. 11. Disconnect the water source at the luer connection 26. 12. Connect the bag of dialysate solution to the dialysis circuit at the connection 8. This leaves the filter 11 and permanent clamp 13 in place to protect the water supply source. 13.
  • a batch container 100 has a fluid quality sensor 135 of a probe 120, such as a contact-type conductivity sensor.
  • a probe 120 such as a contact-type conductivity sensor.
  • the latter may simply be two metallic surfaces separated by a known distance and of a given area that has been calibrated.
  • a cage 135 in a support 105 sealed to the wall 130 of the batch container 100 which may be a polymer bag as typically used in the medical industry.
  • the cage 135 prevents an opposing wall (not shown separately) from preventing fluid from circulating around and through the cage and in contact with the probe such that a reading of the probe 120 is improved.
  • the probe 120 extends from the support 105 and has a lead 122 with a signal connector 125 that can be connected to a controller (discussed later).
  • the probe 120 is an independent element and can be used with any of the embodiments so its description here in combination with other features is not intended to be limiting.
  • the probe assembly is permanently sealed to the batch container such that there is no possibility that contaminants can enter the batch container 100 interior.
  • a fitting connecting a sample or feed line 145 is shown. The latter may be used, with a connector 156, connect a sampling syringe to draw out a sample of a medicament or infusate.
  • a check valve may be provided at 155 to prevent ingress of contaminants.
  • a clamp (not shown separately) may be provided as well to guard against contamination.
  • line 145 may be configured for injecting a soluble concentrate into the batch container 100 before the container 100 is sealed and sterilized as a unit (for example, by gamma ray sterilization).
  • the diluted concentrate may form a medicament or infusate such as replacement fluid for hemofiltration or a dialysate for hemodialysis.
  • Line 145 may also represent a draw line that may be connected to a treatment machine. In the latter case, a sterile filter (at 155),
  • such as a microporous membrane of 0.2 ⁇ may be provided to guard against
  • a clamp may be provided as at 155.
  • purified water may be added to the batch container by another instance of a line similar to 145.
  • concentrate or other medical solute or medication is contained in a separate container, such may be added to the batch container 100 by means of a double lumen spike 174.
  • a spikable bag 170 contains, for example, medical fluid concentrate such as concentrated dialysate.
  • Purified water is pumped through connector 182 of line 180 and passed into the bag (after spiking) by the dual lumen spike 174.
  • the fluid circulates in the bag carrying its contents back through the dual lumen spike 174 through line 172, through a filter 150 into the batch container.
  • the dual lumen spike may be sealed by means of a removable cap 175 so that the batch container and fluid lines can be sealed and sterilized and later delivered as a unit without contamination.
  • Clamps 157 may be provided to seal the batch container 100.
  • a special clamping connector 442 may be provided and used as discussed with reference to Fig. 1B in line 180.
  • a syringe port 240 and check valve 242 are connected inline to the other branch of the Y-junction.
  • a replaceable multiple use filter module 1125 as may be used in the various embodiments described herein has an inlet port 1130 and an outlet port 1110.
  • a physical arrangement of filter cartridges 1111 is shown which provides for a compact module 1125 that is advantageous for packaging and assembling to a chassis (as discussed relative to Figs. 13A and 13B).
  • Tubing 1116 runs from the top of each cartridge 1111 to the bottom to provide upward flow as discussed earlier.
  • a signal port 1100 for reading fluid quality sensors 1115 and 1105 is provided in a housing.1127.
  • Signal port 1100 may have a lead wire and connector installed to it or one may be provided separately. Alternatively, signal port 1100 may be a wireless port powered by a battery. Signal port 1100 may include a data carrier as discussed with reference to Fig. 1 B or a data carrier may be provided separately or without the signal port if a fluid quality sensor is not provided. A data carrier may include software and instructions for using the filter module 1125. These may be read by a permanent component of a filtering system as described in connection with Figs. 13A and 13B.
  • a base unit 335 may be configured substantially as described with reference to Fig. 5 with the base unit 335 housing the components of the permanent pretreatment module 900 and controller module 905.
  • the base unit may contain a display 330, such as an LCD display.
  • the base unit may have a voice generator or other type of output device.
  • An inlet port 341 may be provided for receiving raw water to be filtered and an outlet port 340 for attachment to a filter module (which may be multi- or single-use) which is received in a locating station 315.
  • the latter may have a reader 311 to read a data carrier or to connect with a fluid quality probe such as one or more conductivity sensors described above.
  • a further locating station may be provided such as 305 for a batch container.
  • This may have a data carrier reader 320 and/or various other components (at 321) such as a heater, a mixer, such as a moving field generator for magnetohydrodynamic mixing of the contents of an installed batch container.
  • the base unit 335 may have a port 310 for connection to a fluid quality probe of the batch container. This may provide a calibration input as well as a final measurement of fluid
  • the embodiment of Fig. 13B additionally provides a locating station for a concentrate container such as 170 described with reference to Figs. 9A and 9B.
  • the base unit 335 may further be fitted with a controller containing a computer with a connection to the Internet or other network connecting the base unit with a server 390.
  • features indicated at 301-306 may be added to allow the base unit 335 to control when and whether an outlet line of a batch container should be opened and clamped.
  • a batch container is fitted in the station 305 and an outlet line of the batch container fitted between clamping portions 303 and 304.
  • a detector 306 verifies that the line has been fitted in place.
  • an actuator 302 and motor 301 may be activated to clamp the line during fluid purification and as the batch container is filled. After the batch is filled, the clamp may remain closed until a treatment operation, which may be run while the batch container remains in place, is begun.
  • the clamp mechanism 303 and 304 can enforce the expiration time of the batch of fluid. For example, a timer can be started within the controller of the base unit or, equivalently, a time/date stamp stored and the clamp only released if the batch of fluid is used for treatment within a certain period of time.
  • a treatment machine and the base unit 335 may be combined into a single device under common control or the two may be linked by a data link to operate cooperatively to achieve such a result.
  • a cartridge 271 as illustrated in Fig. 10B may be used instead of a concentrate container in the form a spikable bag 170 as illustrated in connection with Figs. 9A and 9B.
  • concentrate 280 is within a sealed cylinder 274 with a piston 273 and a burstable seal membrane 275.
  • the cartridge may be fitted in the base unit 335 (Figs. 13A and 13B) which may contain a linear drive 270 and plunger 272 to push the piston 273 thereby bursting the seal membrane 275 and inject contents into a T- junction 278 in the path of purified water sent into the batch container 100.
  • the cartridge 271 may be provided as part of the sterile batch container fluid circuit shown in Fig. 9B.
  • the base unit 335 and corresponding parts of other embodiments described herein may contain a programmable controller including an embedded computer 600 with memory, non-volatile storage, communication elements, etc.
  • Various sensors 605 such as discussed in connection with various embodiments may be connected to provide input to the controller executing a program stored in memory. The latter may stored in firmware or obtained from a data carrier via a data port 610 as described previously.
  • a network or Internet connection to a server 625 may be provided to obtain and transmit data such as software, instructions for use, expired identification codes, etc.
  • Actuators 615 such as valve clamps, pumps, and annunciators 620 such as alarms may be provided as well.
  • a sample program for operating the various embodiments described herein is shown in Fig. 15. The process may begin with firmware until software loaded at a later stage takes over. Software may be read from a data port or data store and instructions for using the system output at step S5 whereupon the system waits for user input. The instructions may indicate to press hard or soft key to continue at which point steps S10 and S15 are executed to determine if a no-go condition exists. If a necessary component (S10) has not been connected, step S30 will be executed and the system may output an appropriate message to instruct the user to take corrective action and wait for response.
  • S10 necessary component
  • step S30 will be executed.
  • various system tests may be performed such as a pressure profile test or quality test. Tests may also include determining if the conductivity indicated by a connected conductivity probe is within specified limits.
  • step S25 it is determined if all tests have been passed and control passes to step S35 where fluid preparation is begun. If not, step S 30 is performed and appropriate output is generated on a display such as 330. If a value goes out of range at step S40, control passes to step S60 to determine if an expiration event has occurred, for example, breakthrough of contaminants in a filter module.
  • Filter modules may be "stamped" with a permitted time of use after a first use when presumably the seal was first broken. This may be enforced in the same manner as discussed with reference to attempted reuse of a filter module after breakthrough was detected. Thus, step such an event may be detected at step S60 as well.
  • the expired or spent unit is indicated as expired so that reuse can be prevented.
  • the data carrier may be programmed with a token to indicate that the attached filter module is expired or a server may be sent a message to indicate that its unique ID should be added to a list of expired IDs. Any suitable device may be used to "expire" a unit.
  • step S45 Completion of the treatment may be determined at step S45 by measuring the total mass pumped or by other means. For example, if the embodiment provides a conductivity probe in the batch container, step S45 may depend on the measured conductivity of the batch contents.
  • the system may be halted at step S50 and the batch bag "stamped" with a time and date. Note that further instructions may be output at this point.
  • the water purification and treatment may be done from a single apparatus and under common control. The steps following step S50 illustrate this.
  • step S51 the contents of the container may be mixed, if a solute is involved, and the contents checked in some way in step S51.
  • the conductivity of a mixed batch or the resistivity of a pure batch can be checked determine its conformity with treatment specifications.
  • step S52 if a value is out of range, control passes to step S30, but if not, the batch may be utilized at any time up to an expiration time/date (MTU time, or Mixed Till Use- time).
  • step S53 an outlet clamp that prevents fluid from being drawn from the batch container is released to allow a treatment to be performed with the fluid product.
  • an acceptance message can be output to the user on a display.
  • a time stamp is stored or a timer started to keep track of the expiration of the batch of fluid. If the expiration is not observed, which is tested at step S56 by checking to see if the timer has expired, the clamp will close in step S30 (under the general step indicated as "take action") and an appropriate message output. The system will then wait until treatment is completed while, optionally, continuously checking the MTU timer in steps S46 and S56.
  • a treatment machine 700 when a treatment machine 700 attempts to use a batch container 710 tagged with an expiration date at step S50, it can determine if the date has passed and prevent use of an expired batch container thereafter.
  • This may be implemented with contact or wireless data reading devices, a programmed smart card type device or via an Internet server as described with reference to the mechanism for enforcing non-reuse of filter modules.
  • air may evolve from fluid as it passes through an ultrafilter 714.
  • the ultrafilter 714 has a high membrane surface and in such filters, the potential for air evolution may be fairly high.
  • the embodiment of Fig. 8A shows transducer protectors TP, which are hydrophobic air vents.
  • FIG. 8A A refinement of the configuration of Fig. 8A, which may be used in any water treatment plant as a final protective stage, is to provide an ultrafilter 714 (which may be a standard dialyzer capped at the lower blood port) with an inlet 712 and outlet 704 on one side of the membrane connected by a return line 704 flowing through an air filter/vent 706, through further line 708 into a T-junction 717 and back into the inlet line 712. Ultrafiltered fluid is drawn out through line 707.
  • the filter/vent 706 may be a 1.2 micron air vent with a 1.2 micron hydrophilic membrane that blocks air and a hydrophobic membrane port which allows air to vent from the filter.
  • the water column defined by line 708 is denser than the corresponding column within the housing of ultrafilter 714 so that a return flow will exist through the branch 704, 706, 708.
  • the reason for the lower density is due to the evolution of air in the ultrafilter 714.
  • An alternative design that integrates air vent configurations into the housing of the ultrafilter 714 is shown in Fig. 17A.
  • an air vent e.g., a hydrophobic membrane type air vent 765 may be integrated into the outlet of an ultrafilter 715 and an air filter such as a hydrophilic air filter membrane 766 integrated into the outlet.
  • any bubbles coming out of fluid collect at the top of the filtrate side (in a header space of a microtubular membrane type filter) and be vented by the hydrophobic air vent 765.
  • air collecting in the inlet side will leave by an air vent 467, for example one using a hydrophobic membrane 469.
  • a check valve 742 may be provided to prevent siphoning and/or reduce risk of contamination.
  • a resilient channel element 730 such as an inline bladder 731 may be included with check valves 724 and 728.
  • the resilient channel element 730 When the system pumps fluid, the resilient channel element 730 stores fluid under pressure and releases it in pumping fashion when the system stops pumping. Again, an air filter/vent 724 allows air to escape and purged from the return line 726.
  • the return flow problem can also be dealt with by replacing the T-junction 717 with a Venturi device configured to create a suction in line 708 by using an accelerated fluid flow through the line 714,712.

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  • Water Supply & Treatment (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Environmental & Geological Engineering (AREA)
  • Hydrology & Water Resources (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
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  • External Artificial Organs (AREA)

Abstract

Cette invention concerne des systèmes, des procédés et des dispositifs permettant de préparer de l'eau destinée à diverses applications parmi lesquelles le traitement du sang. Dans certains modes de réalisation décrits dans cette invention, le fluide est acheminé, soit par pompage, soit de manière passive par alimentation par gravité, à travers divers éléments de filtration depuis une source de fluide vers un réservoir de fluide de traitement. Ce dernier constitue une charge qui peut être utilisée pendant un traitement. L'avantage de constituer une telle charge avant le traitement réside dans le fait que la vitesse de filtration peut ne pas correspondre à la vitesse de consommation pendant le traitement, ce qui présente de nombreux avantages. L'invention concerne également des procédés permettant de préparer de l'eau pure pour une perfusion ou des médicaments, lesquels procédés consistent, par exemple, à éliminer le chlore et l'aluminium colloïdal. L'invention concerne également divers procédés de régulation permettant d'éviter une contamination.
PCT/US2005/000381 2003-01-07 2005-01-07 Systeme de filtration permettant la preparation de fluides destines a des applications medicales WO2005068043A1 (fr)

Priority Applications (18)

Application Number Priority Date Filing Date Title
US10/585,675 US20080210606A1 (en) 2004-01-07 2005-01-07 Filtration System Preparation of Fluids for Medical Applications
EP06717769A EP1838356B1 (fr) 2005-01-07 2006-01-09 Systeme de filtrage destine a la preparation de liquides pour applications medicales
DE602006017654T DE602006017654D1 (de) 2005-01-07 2006-01-09 Filterungssystem zur herstellung von flüssigkeiten für medizinische anwendungen
US11/813,472 US9700663B2 (en) 2005-01-07 2006-01-09 Filtration system for preparation of fluids for medical applications
AT06717769T ATE485061T1 (de) 2005-01-07 2006-01-09 Filterungssystem zur herstellung von flüssigkeiten für medizinische anwendungen
JP2007550528A JP4734343B2 (ja) 2005-01-07 2006-01-09 医療アプリケーションに関する溶液準備のための浄化システム
CA2593580A CA2593580C (fr) 2005-01-07 2006-01-09 Systeme de filtrage destine a la preparation de liquides pour applications medicales
PCT/US2006/000608 WO2006074429A1 (fr) 2005-01-07 2006-01-09 Systeme de filtrage destine a la preparation de liquides pour applications medicales
US13/083,915 US8679348B2 (en) 2003-01-07 2011-04-11 Filtration system for preparation of fluids for medical applications
US13/603,505 US8545428B2 (en) 2003-01-07 2012-09-05 Filtration system for preparation of fluids for medical applications
US13/968,430 US9388059B2 (en) 2003-01-07 2013-08-16 Filtration system for preparation of fluids for medical applications
US15/195,801 US10130746B2 (en) 2003-01-07 2016-06-28 Filtration system for preparation of fluids for medical applications
US15/615,655 US10420871B2 (en) 2003-01-07 2017-06-06 Filtration system for preparation of fluids for medical applications
US16/164,047 US11446417B2 (en) 2003-01-07 2018-10-18 Filtration system for preparation of fluids for medical applications
US16/185,525 US20190076589A1 (en) 2005-01-07 2018-11-09 Filtration System for Preparation of Fluids for Medical Applications
US16/423,214 US10973969B2 (en) 2005-01-07 2019-05-28 Filtration system for preparation of fluids for medical applications
US17/212,866 US11896750B2 (en) 2005-01-07 2021-03-25 Filtration system for preparation of fluids for medical applications
US18/396,765 US20240123128A1 (en) 2005-01-07 2023-12-27 Filtration System for Preparation of Fluids for Medical Applications

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/US2004/000476 WO2004062710A2 (fr) 2003-01-07 2004-01-07 Systeme de filtration discontinue destine a la preparation d'un liquide de remplacement sterile pour la therapie renale
USPCT/US04/00476 2004-01-07

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PCT/US2004/000476 Continuation WO2004062710A2 (fr) 2003-01-07 2004-01-07 Systeme de filtration discontinue destine a la preparation d'un liquide de remplacement sterile pour la therapie renale

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US10/585,675 A-371-Of-International US20080210606A1 (en) 2003-01-07 2005-01-07 Filtration System Preparation of Fluids for Medical Applications
US13/083,915 Continuation US8679348B2 (en) 2003-01-07 2011-04-11 Filtration system for preparation of fluids for medical applications

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WO2007030647A2 (fr) 2005-09-07 2007-03-15 Hydranautics Dispositifs de filtration par osmose inverse a debitmetres et conductimetres actionnes par des etiquettes rfid
US7544300B2 (en) 2003-01-07 2009-06-09 Nxstage Medical, Inc. Batch filtration system for preparation of sterile fluid for renal replacement therapy
US7892428B2 (en) 2007-03-06 2011-02-22 Baxter International Inc. Transducer protector
US8192387B2 (en) 2002-06-06 2012-06-05 Nxstage Medical, Inc. Last-chance quality check and/or air/pathogen filter for infusion systems
US9636444B2 (en) 2006-04-07 2017-05-02 Nxstage Medical, Inc. Filtration system for preparation of fluids for medical applications
US9700663B2 (en) 2005-01-07 2017-07-11 Nxstage Medical, Inc. Filtration system for preparation of fluids for medical applications
CN108782185A (zh) * 2018-04-27 2018-11-13 宁夏大学 稻田节水灌排控制方法及控制系统
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CN110723784A (zh) * 2019-10-16 2020-01-24 东莞市鸾江水处理设备工程有限公司 一种废水处理回收方法
CN111714938A (zh) * 2019-03-19 2020-09-29 Fsp流动系统合伙控股股份公司 过滤器盖、过滤装置、过滤系统以及计算剩余寿命的方法

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US8192387B2 (en) 2002-06-06 2012-06-05 Nxstage Medical, Inc. Last-chance quality check and/or air/pathogen filter for infusion systems
US8679348B2 (en) 2003-01-07 2014-03-25 Nxstage Medical, Inc. Filtration system for preparation of fluids for medical applications
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US10973969B2 (en) 2005-01-07 2021-04-13 Nxstage Medical, Inc. Filtration system for preparation of fluids for medical applications
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WO2007030647A2 (fr) 2005-09-07 2007-03-15 Hydranautics Dispositifs de filtration par osmose inverse a debitmetres et conductimetres actionnes par des etiquettes rfid
US9636444B2 (en) 2006-04-07 2017-05-02 Nxstage Medical, Inc. Filtration system for preparation of fluids for medical applications
US11633527B2 (en) 2006-04-07 2023-04-25 Nxstage Medical, Inc. Filtration system for preparation of fluids for medical applications
US10926016B2 (en) 2006-04-07 2021-02-23 Nxstage Medical, Inc. Filtration system for preparation of fluids for medical applications
US7892428B2 (en) 2007-03-06 2011-02-22 Baxter International Inc. Transducer protector
US10189727B2 (en) 2011-12-13 2019-01-29 Nxstage Medical, Inc. Fluid purification methods, devices, and systems
US10947135B2 (en) 2011-12-13 2021-03-16 Nxstage Medical, Inc. Fluid purification methods, devices, and systems
US10189728B2 (en) 2011-12-13 2019-01-29 Nxstage Medical, Inc. Fluid purification methods, devices, and systems
CN108782185A (zh) * 2018-04-27 2018-11-13 宁夏大学 稻田节水灌排控制方法及控制系统
CN111714938B (zh) * 2019-03-19 2022-03-04 雅歌辉托斯集团有限公司 过滤器盖、过滤装置、过滤系统以及计算剩余寿命的方法
CN111714938A (zh) * 2019-03-19 2020-09-29 Fsp流动系统合伙控股股份公司 过滤器盖、过滤装置、过滤系统以及计算剩余寿命的方法
CN110723784B (zh) * 2019-10-16 2022-04-15 东莞市鸾江水处理设备工程有限公司 一种废水处理回收方法
CN110723784A (zh) * 2019-10-16 2020-01-24 东莞市鸾江水处理设备工程有限公司 一种废水处理回收方法

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