USRE36914E - Dialysate filter including an asymmetric microporous, hollow fiber membrane incorporating a polyimide - Google Patents
Dialysate filter including an asymmetric microporous, hollow fiber membrane incorporating a polyimide Download PDFInfo
- Publication number
- USRE36914E USRE36914E US09/250,449 US25044999A USRE36914E US RE36914 E USRE36914 E US RE36914E US 25044999 A US25044999 A US 25044999A US RE36914 E USRE36914 E US RE36914E
- Authority
- US
- United States
- Prior art keywords
- filter
- dialysate
- polyimide polymer
- hollow fiber
- membranes
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired - Lifetime
Links
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- 231100000518 lethal Toxicity 0.000 description 1
- 230000001665 lethal effect Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000003550 marker Substances 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
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- 229910052753 mercury Inorganic materials 0.000 description 1
- 235000019426 modified starch Nutrition 0.000 description 1
- 210000001616 monocyte Anatomy 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 238000005498 polishing Methods 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000037452 priming Effects 0.000 description 1
- 239000003586 protic polar solvent Substances 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 239000002510 pyrogen Substances 0.000 description 1
- 238000012958 reprocessing Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 229920006395 saturated elastomer Polymers 0.000 description 1
- 239000011669 selenium Substances 0.000 description 1
- 229910052711 selenium Inorganic materials 0.000 description 1
- 229910052709 silver Inorganic materials 0.000 description 1
- 239000004332 silver Substances 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 101150035983 str1 gene Proteins 0.000 description 1
- 239000008399 tap water Substances 0.000 description 1
- 235000020679 tap water Nutrition 0.000 description 1
- DVKJHBMWWAPEIU-UHFFFAOYSA-N toluene 2,4-diisocyanate Chemical compound CC1=CC=C(N=C=O)C=C1N=C=O DVKJHBMWWAPEIU-UHFFFAOYSA-N 0.000 description 1
- 229910021642 ultra pure water Inorganic materials 0.000 description 1
- 239000012498 ultrapure water Substances 0.000 description 1
- 239000011800 void material Substances 0.000 description 1
- 238000003260 vortexing Methods 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
- 239000002888 zwitterionic surfactant Substances 0.000 description 1
Images
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
- B01D63/02—Hollow fibre modules
-
- 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
- B01D61/24—Dialysis ; Membrane extraction
- B01D61/30—Accessories; Auxiliary operation
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D69/00—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor
- B01D69/02—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor characterised by their properties
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D69/00—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor
- B01D69/08—Hollow fibre membranes
Definitions
- This invention relates generally to a dialysate filter which is easy to install, durable and cost effective.
- the invention relates to a dialysate filter which removes bacteria and endotoxins from a dialysate stream before it enters an artificial kidney.
- the dialysate filter of the present invention includes improved asymmetrical, microporous, hollow fibers incorporating a polyimide.
- a dialysate filter is a device which can be used in-line, between a dialysis apparatus and an artificial kidney (dialyzer) during hemodialysis treatments, to remove bacteria and endotoxins from the dialysate stream.
- Endotoxins are potentially lethal lipopolysaccharide (LPS) molecules which are released when gram-negative bacteria disintegrate or are destroyed.
- LPS lethal lipopolysaccharide
- Endotoxins can cause Pyrogenic Reactions (PRs) in dialysis patients either directly by passing through an artificial kidney membrane into the patient's bloodstream, or indirectly, by inducing a reaction across the artificial kidney membrane.
- PR(s) are one or more symptoms caused by exposure to endotoxins during dialysis, including fever, chills, hypotension, headache, myalgia, nausea and vomiting. Symptoms usually begin within 30-60 minutes after dialysis has begun, and, vanish shortly after dialysis is stopped. Indirect PR(s) may occur when endotoxins, while remaining trapped within the membrane, still influence changes in a dialysis patient's bloodstream without actually physically contacting the blood.
- the role of endotoxins in the long-term morbidity and mortality of dialysis patients is unclear; however, we do know that endotoxins have the ability to stimulate monocytes to produce chemicals called cytokines. These cytokines induce fever and catabolism in dialysis patients.
- the present invention is a means for preventing PR's by using sterile, non-pyrogenic dialysate during dialysis treatment.
- dialysate filter which solves the problems outlined above that inhibited regular use of a dialysate filter, including difficult to use, expense and safety risks.
- the dialysate filter of the present invention enables the practitioner to quickly and easily install a dialysate filter outside the housing of a dialysis apparatus and thereby effectively monitor the filter and prevent dialysis machine complications. Dialysis machine complications include restricted dialysate flow, increased temperature and leaks.
- the dialysate filter of the present invention works well with a variety of dialysis machines and tolerates a wide variety of disinfecting chemicals without loss of integrity.
- the filter of the present invention includes a housing having an inlet dialysate port, an outlet dialysate port and an access port which function to allow air to be removed and a disinfecting agent to be introduced.
- the housing contains an asymmetric microporous hollow fiber membrane which incorporates a polyimide.
- the filter of the present invention is .[.preferrably.]. .Iadd.preferably .Iaddend.a dialysate filter which is attached to a dialysis apparatus.
- the dialysis apparatus includes a housing, a dialyzer within the housing and a dialysate inlet port to the dialyzer.
- the apparatus is connected with the dialysate filter through a female to female connector.
- the filter is located upstream of the dialyzer outside the housing.
- the dialysate filter of the present invention creates dialysate which is bacteria free and non-pyrogenic.
- the filter should be used as a preventative measure or in the event of Pyrogenic Reaction, a bacterial culture growth exceeding AAMI limits or a LAL assay indicating that endotoxin levels are in excess of 5 EU/ml or 1 ng/ml.
- FIG. 1 depicts a dialysis apparatus with a dialysate filter of the present invention installed thereon.
- FIG. 2 depicts a dialysate filter of the present invention and its connectors.
- FIG. 3A is an enlarged, microscopic, cross-sectional view of the hollow fiber membrane in accordance with the present invention illustrating the "homogeneous sponge-like" structure.
- FIG. 3B is a greatly enlarged view thereof taken from the area enclosed by box 3B in FIG. 3A.
- FIG. 4 is an enlarged detailed view of the hollow fiber membrane in accordance with the present invention illustrating the homogeneous sponge-like structure taken at a 45° angle of cross-section.
- FIG. 5A is an enlarged, microscopic cross-sectional view of prior art hollow fiber membranes illustrating "voids.”
- FIG. 5B is a greatly enlarged detail view thereof taken from the area enclosed by box 5B in FIG. 5A.
- FIG. 6 is an enlarged, microscopic cross-sectional view of hollow fiber membranes with voids.
- FIG. 7 illustrates the pressure drop versus conductivity for a polyimide filter.
- FIG. 8 illustrates a comparison of pressure drop in water for a variety of filters.
- FIG. 9 illustrates a comparison of pressure drop in dialysate between polyimide containing filters and polysulfone containing filters.
- the present invention is directed to a filter membrane, a dialysate filter and a dialysis apparatus.
- the membrane and dialysate filter are discussed in connection with their use in dialysis, the skilled artisan would clearly recognize the applicability of the membrane and filter to other technology areas. These areas include water filtration, as a polishing filter for pharmaceutical production, as a plasma filtering device, as a chemofilter, as a hemoconcentrator, and the like.
- Dialysate as used herein refers to the final solution, blended within the dialysis apparatus, from sodium bicarbonate concentrate, acid electrolyte concentrate, and ultra-pure water, which flows in a single pass through the dialysate filter and artificial kidney and then finally to drain.
- An in-line filter installed in the dialysate line of a dialysis apparatus, will block passage of most endotoxins contained within reverse osmosis water or the final dialysate stream of the dialysis apparatus.
- the filter will prevent high loads of endotoxin from reaching the dialysate compartment of the artificial kidney during dialysis and causing Pyrogen Reactions in dialysis patients.
- the filter membrane of the present invention produces a dialysate which is bacteria free and non-pyrogenic.
- Baceria free as used herein means that no bacteria is detectable as determined by a filter effluent sample's lack of bacterial growth in an optimum environment for growth.
- Non-pyrogenic means that no endotoxins are detectable as determined by the gel-clot method of Limulus Amebocyte Lysate (LAL) assay of filtrate, or levels of pyrogenic material are so low no PR will occur during dialysis.
- “Filtrate” refers to the dialysate outflow or effluent from the filter.
- the filter membrane of the present invention is particularly well suited for these applications as it is easy to install, maintain and sterilize.
- the filter membrane in one embodiment of the present invention will tolerate a dialysate flow of from 300 ml/min to 1000 ml/min, and will also tolerate a wide variety of disinfection regimens and chemicals.
- the dialysate filter of the present invention is comprised of a housing (1) having a dialysate inlet port (2), a dialysate outlet port (3) and an access port (4). Inside the housing is a filter comprising a bundle of fibrous-membranes.
- the housing can be made of any appropriate material which includes polycarbonate, polypropylene, polyethylene, mixtures thereof and the like. Preferably polycarbonate forms the housing.
- the housing is connected to the dialysate inlet port on a dialysis apparatus (5) through a female to female "Hansen” or “Walther” connector (6).
- the connector (6) may be attached directly to the dialysate outlet port of the filter (3) or may be connected via a hose or other interposed connection means to the outlet port (3).
- the connector (6) may take any shape but preferably is a straight-line connect, a 45° angle connect or a 90° angle connect. More preferably, the connector is a 90° angle connect.
- the fiber membrane contained within the housing may be made of any highly permeable filter medium, for example, polymeric fibrous membranes. These membranes can be formed of polysulfone, polycarbonate, polyimide and the like.
- the filter is preferrably made up of asymmetric microporous hollow fiber membranes.
- the filter contains asymmetrical microporous, hollow fiber membranes that include a polyimide polymer that is highly polar.
- microporous to mean membranes having a pore size ranging from about 0.005-0.2 ⁇ m.
- flux or water permeability to mean a measure of the volume of water passed by the hollow fiber membrane under pressure for a given time and area.
- Rewetting and similar words such as rewettable, rewettability, etc., as used herein, is a description of the ability of a membrane to maintain a particular level of flux or water permeability after either cycles of wetting and drying the membrane or after steam or chemical sterilization.
- Asymmetric means that the pore size of the fiber varies from smaller to larger from the inner barrier layer to the outer sponge-like layer, respectively.
- "Uniformly porous” and “sponge-like” means that the porosity of the hollow fiber membrane is homogeneous throughout.
- solvents with respect to the polymer are typically aprotic solvents while “non-solvents with respect to the polymer” are typically protic solvents.
- Anti-solvent is a nonsolvent with respect to the polymer and is used herein when referring to additional nonsolvents that are added to the polymeric solution.
- “Nonsolvents,” on the other hand are also nonsolvents with respect to the polymer, but is used herein when referring to nonsolvents added to the precipitating solution.
- the highly polar polymer in accordance with the present invention is preferably an aromatic polyimide that when precipitated as a membrane is immediately wettable without the use of polymer additives or surfactants.
- the preferred polyimide in accordance with the present invention is disclosed in U.S. Pat. No. 3,708,458 to Alberino which is incorporated herein by reference, in its entirety.
- the polyimide is prepared from benzophenone3,3',4,4'tetracarboxylic acid dianhydride and a mixture of 4,4' -methylenebis(phenylisocyanate) and toluene diisocyanate (2,4- or 2,6-isomer) or mixtures thereof.
- the polyimide includes the recurring group: ##STR1## wherein 10% to 90% of the R groups are ##STR2## and the remaining R groups include either ##STR3##
- the aromatic iso- and diisocyanates may be substituted by their amine analogs.
- the CAS Registry No. of the preferred polyimide is 58698-66-1.
- the polyimide is available from Lenzing Corp. (Austria) under the P84 and/or HP P84 (high purity) marks.
- a polymer based on the phenylindane diamine; 5(6)-amino-1-(4'-aminophenyl)-1,3-trimethylindane with a CAS Registry No. of 62929-02-6 may be used.
- the alternative embodiment polymer is available from Ciba-Geigy Corporation (Hawthorne, N.Y.) under the Matrimid 5218 mark.
- the alternative preferred embodiment may be prepared by the methods disclosed in U.S. Pat. No. 3,856,752.
- the polyimide polymers useful in accordance with the present invention preferably have a molecular weight of about 30,000 to 125,000 daltons. More preferably, the molecular weight is about 35,000 to 115,000 daltons and most preferably, the molecular weight is about 40,000 to 105,000 daltons.
- the elimination of additives in the polymeric dope solution decreases and virtually eliminates all but trace amounts of solids and/or oxidizable material that is leachable from the resultant fiber. Further, the structural integrity of the resultant hollow fiber membrane is more stable after the removal of the solvent and/or antisolvents and nonsolvents.
- the polyimide polymer is dissolved in a solvent including solvent/antisolvent combinations.
- this solvent is also miscible with water.
- a representative, non-limiting list of solvents useful in the invention includes dimethylformamide (DMF), dimethylsulfoxide (DMSO), dimethylacetamide (DMA), n-methylpyrrolidone, and mixtures thereof.
- the solvent is DMF, an aprotic solvent.
- an antisolvent may be added in small quantities to the primary solvent that is used. The addition of an antisolvent in the polymer forming solution will enhance the desired precipitate characteristics of the polymer during fiber formation.
- adding acetic acid in the amount of 4-7 wt. % ensures that the fiber has a uniform sponge-like structure, free of voids, large vacuous spaces extending from the inner membrane wall to the outer membrane wall that can permit the passage of large molecular weight molecules if the void pierces the inner and/or outer membrane wall.
- additional amounts of solids may be added to the polymer solution up to 25.0 wt. % to solve this problem.
- the homogeneous, sponge-like structure may also be achieved in accordance with the process and formulations described herein.
- FIG. 3 depicts a cross section of a hollow fiber membrane in accordance with the present invention magnified 130 ⁇ taken on a Hitachi 5-800 scanning electron microscope.
- FIG. 3B which is a 10 ⁇ magnification (1300 ⁇ ) of the area enclosed by box 4B in FIG. 3A and illustrates the "uniform sponge-like structure 200 of hollow fiber membranes in accordance with the present invention.
- FIG. 4 is a 10,000 ⁇ view taken at a 45° angle of cross-section of hollow fibers in accordance with the present invention showing the outer membrane wall 210 and the sponge-like inner composition 215.
- "Voids" 220 which characterize many hollow fiber membranes, may be seen by referring to FIGS. 5A (130 ⁇ ) and 5B (1300 ⁇ ). The absence of voids in the formed hollow fiber membrane results in a mechanically stronger fiber with enhanced diffusion rates.
- the fibers formed may not be strong enough to withstand the stresses involved in the high speed process in the preferred method of manufacturing the fiber membrane used in the present invention. Further, the fibers lack integrity due to the weakness from the voids in the fiber walls.
- Higher polyimide solids may be employed in organic solvent systems if spinerette housings, feed lines, polymer solution tanks are heated. Upon heating, the viscosity of the polymer solution is lowered, allowing otherwise unusable polymer solution formulations to be spun. Depending upon the composition of the precipitating solution the skilled practitioner chooses, heating and/or cooking the system may influence the morphology and performance characteristics of the resultant fiber membrane.
- the polymeric solution has a viscosity of about 1500-5000 cps, preferably about 2000-4000 cps, and most preferably about 3600 to 4900 cps at 25° C., as measured on a Brookfield (LV) viscometer.
- the solution is preferably filtered to remove any entrained particles (contaminants or undissolved components) to prevent apparatus blockage.
- the polymeric solution is spun from the outer, annular orifice of a tube-in-orifice spinerette.
- a precipitating solution is delivered to the tube of the spinerette.
- the precipitating solution includes a solvent with respect to the polymer and a non-solvent with respect to the polymer or a variety of non-solvents.
- the composition of the precipitating solution is critical because it affects the porosity, degree of uniform sponge-like structure, clearance, tensile strength, wall thickness, inner and outer diameters and flux properties of the fiber.
- composition of the precipitating solution effective to produce a hollow fiber membrane for use in hemodialysis as well as, water filters, autologous blood filters, and plasma filters is illustrated below in Table I.
- the table above is merely offered to guide the practitioner in formulating precipitating solution. Indeed, the practitioner may decide that it is advantageous to operate in a "Preferred" range for one component while operating in a “Most Preferred” range for another. In addition, depending on which formulation of precipitating solution the practitioner selects, he or she may also vary the percent solids in the polymer solution to obtain a fiber of the desired characteristics.
- the water which may be used in the precipitating solution may be tap water, deionized water or water which is a product of reverse osmosis.
- the water has first been treated by reverse osmosis.
- the solvent (with respect to the polymer) used in the precipitating solution is dimethylformamide (DMF), dimethylsulfoxide (DMSO) dimethylacetamide (DMA), n-methylpyrrolidone and mixtures thereof.
- the solvent is the same as that used in the polymeric fiber forming solution. More preferably, the solvent is DMA or DMF. Most preferably, the solvent is DMF.
- solvents and non-solvents which may or may not contain salts, may be used so long as they are miscible with dimethylformamide, dimethylsulfoxide, dimethylacetamide, n-methylpyrrolidone and mixtures thereof.
- a representative, non-limiting list of non-solvents (with respect to the polymer) that may be used in the precipitating solution are acetic acid, isopropanol, water, glycerol, acetic anhydride, and ethanol.
- the proportions of the water, and other non-solvents which may make up the precipitating solution influence the morphology, clearance, permeability, and selectivity characteristics of the hollow fiber membrane.
- the total absence of a solvent with respect to the polymer in the precipitating solution may result in a small number of pores in the fiber wall as well as lower flux.
- water is clearly an important ingredient in the precipitating solution used in this membrane formation process.
- the proportion of water in the precipitating solution be about 1-35 wt. %, to ensure proper fiber performance characteristics. Less than about 10 wt. % of water may result in the polymeric solution precipitating too slowly forming a fiber with increased pore size. This is desirable to form a fiber for use in water filters but would not, for example, form a fiber suitable for use as a dialyzer fiber. Conversely, a concentration of water greater than about 35 wt. % results in a fiber with lower pore density on the outside and a tighter closed inner wall with a general decrease in flux. However, when the proportion of water falls within 1-35 wt.
- the hollow fiber membranes may be formed using tube-in-orifice spinning procedures as disclosed in the .[.copending.]. .Iadd.abandoned.Iaddend., commonly assigned applications Ser. No. 07/684,585, filed Apr. 1, 1991 entitled “Improved Fiber Spinning Process for the Preparation of Asymmetrical Microporous Hollow Fibers” and Ser. No. 07/902,389, filed Jun. 23, 1992 entitled “Hollow Fiber Membrane Incorporating a Surfactant and Process for Preparing Same," the disclosures of which are hereby incorporated by reference.
- the highly polar polymer is diluted in DMF.
- a small amount of a non-solvent (with respect to the polymer) also called anti-solvents
- a non-solvent also called anti-solvents
- water may be added instead of using pure DMF solvent.
- a non-solvent also called anti-solvents
- This may enhance the precipitation of the polymer in the fiber formation.
- the addition of 4-7 wt. % glacial acetic acid to the polymer/DMF solution enhances the uniform sponge-like structure of the resultant fiber and the fiber is further characterized by the complete absence of voids.
- the polymeric dope solution is pumped, filtered and directed to the outer, ring orifice of a tube-in-orifice spinerette.
- the precipitating solution is pumped to the inner coaxial tube of the spinerette.
- These two solutions are then delivered from the spinerette in a manner such that the polymer dope forms an annular sheath surrounding a flow of precipitating solution within the annulus.
- the spinerette head is maintained at a temperature of about 5°-85° C., more preferably, about 15°-25° C., and most preferably, 23°-24° C. The 23.9° C.
- polymeric dope is subjected to a pressure of about 0-1400 kPa, more preferably, about 140-1000 kPa, and most preferably, about 150-750 kPa.
- the polymer dope is spun through a ring orifice having an outside diameter of about 0.018 to 0.040 inches (about 460 to 1,016 microns) and an inside diameter of about 0.008 to 0.010 inches (about 200 to 280 microns).
- precipitating solution is pumped through the tube of the spinerette at a pressure of about 0-1000 kPa, preferably about 0-100 kPa, and most preferably, about 1-20 kPa.
- the precipitating solution or diluent solution is delivered through a tube having an outside diameter of substantially about 0.010 inches (about 254 microns) and an inside diameter of substantially about 0.004 to 0.005 inches (about 100 to 127 microns).
- the polymer dope in order to produce a hollow fiber having an approximately 190-230 micron inside diameter and a wall size of 30-45 microns, is delivered to the spinerette at a rate of substantially about 1.0-10 mL/min, more preferably, about 2-5 mL/min, most preferably, about 3-4.5 mL/min, and the precipitating solution is delivered at a rate of at least about 1.0-10 mL/min, more preferably, about 2-5 mL/min, and most preferably, about 2-3 mL/min.
- the spinerette is oriented in a manner such that fiber production is driven by fluid flow and by removal from the spinerette by gravity effects.
- the fiber emerges from the spinerette and is pulled by gravity and the take-up speed in a nearly vertical direction downwards.
- laminar fluid flow should be maintained both within the spinerette head for the polymeric solution and the precipitating solution which interact to precipitate the formed fiber. If turbulent flow is present in the spinerette head, especially within the channels which convey the polymeric dope, gas pockets may develop and ultimately form large voids in the spun fiber. Turbulent flow-within the spun fluids may also result in voids within the fiber.
- ratios of the annular orifice for passage of the polymeric dope and the coaxial tubular orifice for passage of the diluent or precipitating solution are helpful to visualize the spinerette dimensions by resort to ratios of the annular orifice for passage of the polymeric dope and the coaxial tubular orifice for passage of the diluent or precipitating solution.
- One helpful ratio is the ratio of the cross-sectional area of the annular orifice to tubular orifice.
- the ratio is greater than about 1:1, more preferably, the ratio is about 3:1 to 25:1, and most preferably, the ratio of the annular orifice to tubular orifice cross-sectional area is about 4:1 to 15:1.
- the annular ring thickness to tube inside diameter is the annular ring thickness to tube inside diameter.
- the ratio is greater than about 1:1, more preferably, the ratio is about 1.5:1 to 7:1, and most preferably, the ratio of the annular ring thickness to tube inside diameter is about 2:1 to 6:1.
- a third helpful dimensional ratio is the outside diameter of the annular orifice to tube inside diameter.
- this ratio is greater than about 2:1, more preferably, the ratio is about 3:1 to 10:1, and most preferably, the ratio of the annular outside diameter to tube inside diameter is about 4:1 to 8:1.
- the fiber As the fiber emerges from the spinerette, it drops in a substantially downward vertical direction over a distance of about 0.1-10 m, more preferably, about 0.5 to 2.0 m, and most preferably, about 0.5 to 1.5 m. This allows the precipitating solution to substantially precipitate the polymer in the annular dope solution forming the solid fiber capillary before it is immersed in a quenching solution. Between the spinerette and the quenching bath, the fiber drops through the atmosphere, air, air with a particular relative humidity, an augmented atmosphere, e.g., a mixture of air or air with a particular relative humidity and a gas, an inert gas, or a mixture thereof.
- an augmented atmosphere e.g., a mixture of air or air with a particular relative humidity and a gas, an inert gas, or a mixture thereof.
- the fiber drops through air maintained at a temperature of 0° C. to 100° C., more preferably, the air is maintained at a temperature of 5° C. to 50° C. and most preferably at 15° C. to 25° C.
- the air is also maintained at a relative humidity of substantially about 10% to 99%, more preferably from substantially about 20% to 80% and most preferably from substantially about 40% to 65%.
- This gaseous atmosphere may be relatively stagnant, or there can be fluid flow.
- the flow rate is sufficient to allow complete air change over in the spinning environment once every 30 minutes.
- the gas flow is about 10 L/min.
- the fiber may be dropped directly into the quenching bath.
- the fiber is submerged in a tank comprising water and 0-10 wt. % other materials.
- the water may be tap, or any purified water including deionized water, or the product of a reverse osmosis process.
- the temperature of the quenching bath is preferably between about 0° C. to 100° C., more preferably, about 15° C. to 45° C., and most preferably, about 35° C.
- the water temperature directly affects-the performance of the fiber. Lower temperatures can reduce the flux of the resulting fiber. Increasing the quenching bath temperature can increase the flux of the fiber.
- the fiber is preferably immersed in the quenching bath for a period of about 0.1 to 10 seconds, preferably about 0.1 to 5 seconds, and most preferably, about 1 second. This residence time permits the full precipitation of the polyimide polymer to form the microporous hollow fiber.
- the fiber may be further rinsed to remove any remaining solvents.
- This rinsing may be accomplished in a water bath arrangement.
- the additional rinse is achieved in a water bath having a water temperature of about 0° C.-100° C., more preferably, about 15° C.-45° C., and most preferably, about 35° C.
- the fiber is then wound on a take-up reel.
- the take-up reel is preferably rotating at a speed such that the fiber is being wound at about 90-175% of the rate at which it is being formed at the spinerette or, in other words, at approximately about 150-250 ft/min (about 45-77 m/min).
- the fiber is being wound at a rate substantially equal to that at which it is being produced.
- the fiber is taken up with enough speed (i) to create a fiber of the desired size and (ii) to apply sufficient tension to the fiber such that it will remain taut in the take-up guide unaffected by ambient air currents, i.e. there is no "draft.”
- the hollow fibers may then be dried by any method appropriate to general manufacturing procedures including but not limited to air, heat, vacuum, or any combination thereof.
- the hollow fibers may be further processed to form useful articles including hemodialyzer cartridges, hemofilters, blood filters, water filters, etc., having improved performance levels.
- polyimide fibers are preferred over polysulfone because they have a lower pressure drop across the filter, i.e., they are more permeable.
- the filter of the present invention preferably contains a bundle of fibers which are anchored within the housing by a potting composition.
- the preferred potting composition of the present invention is urethane.
- the fiber bundle within the housing should contain sufficient fibers to achieve the objectives of the filter as disclosed, however, the skilled practitioner would understand that the number of fibers may be modified so that the necessary permeability of the filter is maintained.
- the number of fibers is preferably between 4500 and 5000 fibers per bundle.
- the filter of the present invention is preferably attached via a Hansen connector.
- the filter is attached to the dialysis apparatus at the inlet dialysate port outside the housing immediately upstream of the artificial kidney or dialyzer.
- the filter of the present invention may be installed within the dialysis apparatus housing, however, it will be more difficult to clean and evaluate based upon that location.
- the filter may also be placed further upstream of the dialyzer, however, upstream placement runs an added risk of recontamination of dialysis fluids.
- the pressure drop across the filter can be easily monitored.
- the pressure drop is indicative of flow characteristics of the dialysate and can indicate dialysis machine complications, including restricted flow, leaks, or an increase in temperature.
- the filter may be installed or replaced while a dialysis treatment is ongoing. Accordingly, in the event of a rupture of the filter, the unit can be quickly and easily replaced without any added risk to the patient.
- the filter can be used with any hemodialysis machine but is preferably used with single pass ultrafiltration controlled hemodialysis machines.
- the preferred dialysate filter of the present invention has the properties set forth in the Table below:
- the filters should be stored between 0° and 35° C., and excessive changes in humidity should be avoided.
- the filter of the present invention should be disinfected daily.
- Preferred disinfectants include acetic acid based sterilants available under the tradenames Actril and Renalin Cold Sterilant, bleach and heat treatment.
- the filter is replaced preferably within 30 days.
- the filter should also be replaced in the event the pressure across the filter rises or drops to unacceptable levels.
- the filter is replaced if the pressure drop across the filter is greater than 155 mmHg (3 PSI) or less than 52 mmHg (1 PSI).
- Examples 1-7 characterize and describe how to prepare the polyimide fibers according to one preferred embodiment of the present invention.
- Examples 8-29 describe the preparation, testing, cleaning and use of the filters of the present invention.
- a polymeric dope solution was formed by dissolving 17.5 wt. % of P84 in dimethylformamide. The material was filtered and then pumped to a tube-in-orifice spinerette at a rate of 4.50 mL/min and at a temperature of 24° C. Simultaneously, a precipitating solution consisting of 80 wt. % dimethylformamide and 20 wt. % reverse osmosis deionized water was mixed, filtered and delivered to the spinerette at a temperature of 24° C. and a rate of 2.75 mL/min.
- the polymeric dope solution was delivered through the outer, annular orifice of the spinerette, which orifice had an outside dimension of about 0.022 to 0.025 inches (about 560 ⁇ m) and an inside dimension of about 0.010 inches (about 254 ⁇ m).
- the precipitating solution was delivered through a tube-in-orifice within the annular orifice, which tube-in-orifice had an inside diameter of about 0.005 inches (about 127 ⁇ m).
- the spinerette head was maintained at 24° C.
- the spinerette discharged the polymeric solution and precipitating solution downward into ambient atmosphere for a distance of about 1.5 meters into a quenching bath maintained at 32° C.
- Formed fiber material was wound on a take-up reel at a rate of 70 m/min. The fiber was then removed from the take-up wheel, cut, bundled, soaked in a water bath at 32° C. for 10 hours, dried and tested.
- Fiber membranes prepared by the method recited in Example 1 had sieving coefficients of 0.0 for albumin, 1.0 for myoglobin and 1.0 for inulin.
- the method for preparing fiber as in Example 1 was repeated using a precipitating solution of 81 wt. % DMF and 19 wt. % deionized water.
- Resultant fiber membranes had sieving coefficients of 0.0 for albumin, 1.0 for myoglobin, and 1.0 for inulin.
- Example 1 The method employed in Example 1 was repeated using 17.0 wt. % of the P84 polyimide polymer and 83 wt. % DMF.
- the precipitating solution comprised 81 wt. % DMF and 19.0 wt. % deionized water. Sieving-coefficients were similar to the Test Data obtained for Examples 1 and 2 above.
- Fibers for use in a water filter were manufactured in the following manner.
- a polymeric dope solution was formed by dissolving 19.0 wt. % of Matrimid 5218 in 81.0 wt. % DMF.
- the material was filtered and then pumped to a tube-in-orifice spinerette at a rate of 2.9 mL/min at a temperature of 23° C.
- a precipitating solution consisting of 85.5 wt. % DMF and 14.5 wt. % water was mixed, filtered and delivered to the spinerette at a temperature of 23° C. and a rate of 3.0 mL/min.
- the polymeric dope solution was delivered through the outer, annular orifice of the spinerette having an outside diameter of 940 ⁇ m and an inside diameter of 254 ⁇ m.
- the precipitating solution was delivered through a tube-in-orifice within the annular orifice having an inside diameter of about 127 ⁇ m.
- the spinerette head was maintained at about 23° C.
- the spinerette discharged the column of polymeric/solution and precipitating solution downward for a distance of about 0.81 m into a quenching water bath maintained at a temperature of 35° C.
- the fiber was wound on a take-up reel at a rate of about 45 m/min. Cut bundles were soaked in a 46° C. water bath for 16 hours. Fiber bundles were dried and tested. Based on a 0.05 m 2 test mat, at 5 psi, water permeability was calculated to be 500 mL/(hr ⁇ m 2 ⁇ mmHg).
- Fibers for use in a plasma filter were manufactured in the following manner. The method for preparing fiber as in Example 4 was repeated using a polymeric dope solution consisting of 16.75% P84 polymer and 83.25 wt. % DMF. The precipitating solution included 85.5 wt. % DMF and 14.5 wt. % deionized water. Fibers had a sieving coefficient of 0.65 using a 0.1% solution of fluorescein isothiocyanate dextran (Sigma), a molecular weight marker of approximately 500,000 Daltons. Water permeability was in excess of 900 (mL/hr/mmHg/m 2 ).
- Fibers for use in a water filter were manufactured in the following manner.
- a polymeric dope solution was formed by dissolving 16.75 wt. % P84 polymer in 83.25 wt. % DMF.
- the material was filtered and then pumped to a tube-in-orifice spinerette at a rate of 4.5 mL/min at a temperature of 23° C.
- a precipitating solution consisting of 85.5 wt. % DMF and 14.5 wt. % water was mixed, filtered and delivered to the spinerette at a temperature of 23° C. and a rate of 3.0 mL/min.
- Fibers were further processed in accordance with the method of Example 4. .[.Fibers were further processed in accordance with the method of Example 4..].
- a water filter (1.5 m 2 of fiber) containing the fibers manufactured using the above formulation was tested for water permeability. At 8.6 psi, filters had a water permeability of 1020 ml/(hr ⁇ m 2 ⁇ mmHg). At 10.0 psi, filters had a water permeability of 1320 ml(hr ⁇ m 2 ⁇ mmHg).
- Fibers for use in water filters were prepared in the following manner.
- a polymeric dope solution was formed by dissolving 15.2 wt. % P84 polyimide polymer in 79.80 wt. % DMF and 5.0 wt. % glacial acetic acid.
- the material was filtered and pumped to a tube-in-orifice spinerette at a rate of 4.1 mL/min.
- a precipitating solution comprised of 50 wt. % DMF and 50 wt. % glacial acetic acid was mixed, filtered and delivered to the spinerette at a rate of 4.5 mL/min.
- the polymeric dope solution was delivered through the outer, annular orifice of the spinerette having an outside dimension of about 0.029 inches (737 ⁇ m) and an inside dimension of about 0.01 inches (about 254 ⁇ m).
- the precipitating solution was delivered through a tube-in-orifice within the annular orifice having an inside diameter of about 0.005 inches (about 127 ⁇ m).
- Precipitated fiber was quenched in a reverse osmosis water bath and taken up at a rate of 49 m/min.
- a dialysate filter was prepared by spinning hollow fibers incorporating a polyimide. The dried fiber bundles were inserted into the molded polycarbonate case. Special potting caps were placed at the ends of the molded polycarbonate case. The ends of each fiber were cut to size. Urethane potting material was then centrifugally placed in the case to seal the fibers to the case. Excess potting material was cut away to expose the ends of the fibers and provide a fluid flow path in the completed dialysate filter. Once the ends of the filter were potted and cut, polycarbonate headers fitted with an O-ring were placed on the ends of the case. A cap was placed over the access port.
- the filter had the following properties:
- a NEO-1 Dialysate Meter from Automata Medical Instrumentation Inc. in Arizona measured conductivity upstream and downstream of the dialysate filter described above.
- the meter contains a flow-through conductivity cell having a temperature sensor for temperature compensation.
- the cell attached to the dialysate lines with Hansen®-style fittings.
- the electrolyte composition was analyzed at the filter inlet and outlet for a dialysate filter as described in Example 8.
- the dialysate filter was installed on a Travenol 450 SPS dialysis machine between the dialyzer-inlet and dialyzer-outlet lines. A throughput flow at 600 ml/min was initiated and concentrate uptake lines were connected to sterile, non-pyrogenic liquid bicarbonate and acid electrolyte concentrate containers. Concentrates were diluted internally by the Travenol 450 SPS using reverse osmosis water meeting the AAMI standards for water used to make dialysate.
- the dialysate conductivity was allowed to stabilize as indicated by a conductivity reading taken at the filter inlet stream. We also waited until the machine issued no dialysate-related alarm conditions, including over-pressure, temperature varying from 37° ⁇ 2° C. Throughput of the dialysate at 600 ml/min was continued for 30 minutes. Using a "clean-catch" technique, samples of at least 200 ml/min were collected at the filter inlet and outlet in acid washed polyethylene bottles. These bottles were sent to an outside laboratory for testing. The results of the tests were as follows:
- Filtrate conductivity 0.169 ⁇ S/cm (or 0.37 ppm). This was an increase from the inlet DI water conductivity of 0.066 ⁇ S/cm (or 0.145 ppm). Therefore, approximately 0.224 ppm (or 224 ppb) of unknown ionic shedding or release of dissolved solids can be attributed to the filter.
- the filter inlet and outlet pressures were observed in water and final bicarbonate-based dialysate for a filter as described in Example 8.
- the transmembrane pressure drop was also examined as it related to the filter's effect upon the dialysate stream pressures and flow rates.
- a filter as described in Example 8 was installed on a Travenol 450 SPS dialysis machine between dialyzer-in and dialyzer-out dialysate lines.
- the sample port Tees, with 3-way stopcocks attached were installed in the upstream and downstream lines.
- Tubing was attached between the stopcocks and the Digi-dyne - pressure monitor transducers (one for filter inlet pressure and one for filter outlet pressure). The stopcocks were opened to the monitoring tubing and turned on the pressure monitors.
- dialysate throughput flow was initiated by connecting concentrate uptake lines to sterile, non-pyrogenic liquid bicarbonate and acid electrolyte concentrate containers.
- Concentrates were diluted internally by the Travenol 450 SPS using RO water meeting the AAMI standards for water used to make dialysate.
- dialysate conductivity was allowed to stabilize as indicated by a NEO-1 Dialysate Meter reading of .Iadd.the .Iaddend.filter inlet stream. We also waited until the machine issued no dialysate-related alarm conditions.
- a throughput of 37° C., properly proportioned, bicarbonate-based, final dialysate was continued at 600 ml/min for 30 minutes.
- the transmembrane pressure drop across the filter was observed during dialysate throughput. Again, it was determined if the filter functioned as a flow restrictor by measuring flow in the drain line with a graduated cylinder over a one minute period.
- the filter displayed a one-time variance in pressure drop that is corrected the first time each filter contacts final dialysate solution.
- the initial transmembrane pressure drop at 600 ml/min in RO water is about 260-340 mmHg initially.
- the TMP drop falls to about 200 mmHg and is stable.
- the figure shows how we cycled back and forth between RO water and dialysate three times to illustrate the permanence of the change in pressure drop once dialysate contact occurs. At no time did the filter function as an actual in-line flow restrictor.
- Sample port Tees with 3-way stopcocks attached, were installed in the upstream and downstream lines.
- Tubing was attached between the stopcocks and Digi-dyne® pressure monitor transducers (one for filter inlet pressure and one for filter outlet pressure). The stopcocks were opened to the monitoring tubing and the pressure monitors were turned on.
- RO water throughput flow at 600 ml/min was initated and maintained for at least five minutes to allow conditions to stabilize.
- the flow rate was verified by measuring flow in the drain line with a graduated cylinder over a one minute period.
- the inlet and outlet pressures were recorded and the transmembrane pressure drop across the filter was calculated.
- dialysate throughput flow was initiated by connecting concentrate uptake lines to sterile, non-pyrogenic liquid bicarbonate and acid electrolyte concentrate containers.
- the acid concentrate used was Renal Systems® SB-1075 and the bicarbonate concentrate used was BC-1-L.
- Concentrates were diluted internally by the Travenol 450 SPS using RO water exceeding the AAMI standards for water used to make dialysate.
- the time count began at "0" when concentrate .[.is.]. .Iadd.was .Iaddend.hooked up to the dialysis machine.
- the inlet and outlet pressures were recorded and the transmembrane pressure drop across the filter was recorded every minute up to 10 minutes.
- the concentrate containers were then disconnected. After five minutes, a final measurement of inlet and outlet pressures was recorded and a final transmembrane pressure drop was calculated.
- Steps one through five were repeated for a dialyzer using the same membrane as the RenaGuardTM Dialysate Filter (polyimide), a Minntech Primus®1350 dialyzer (polysulfone), and a Fresenius F60 dialyzer (polysulfone).
- Dialysate TMP drop measurements were done for the Fresenius F80 dialyzer and Fresenius DIASAFE hemodiafiltration unit for comparison to the RenaGuardTM Dialysate Filter in the dominant fluid environment, i.e., final dialysate.
- the RenaGuardTM Dialysate Filter had a lower pressure drop in dialysate than either the Fresenius F80 dialyzer or the Fresenius DIASAFE hemodiafiltration filter. The results are set forth in FIG. 9.
- a "mock dialysis treatment” was set up with the dialysate filter as described in Example 8 installed immediately pre-dialyzer on a ultrafiltration-controlled (UFC) dialysis machine.
- the purpose of the mock dialysis treatment was to verify that the "treatment” could proceed from start to finish without alarm conditions caused by the filter, and, that the fluid removal goal for the "treatment” was within 2% of programmed goal.
- a filter as described in Example 8 was installed on a Fresenius A2008H UFC dialysis machine between dialyzer-in and dialyzer-out dialysate lines. This configuration is set forth in FIG. 1.
- Setup conditions included priming a Fresenius F60 dialyzer with normal saline, installing it on the A2008H machine utilizing the blood pump, pressure monitor lines, and a bucket containing saline to simulate the "patient".
- Blood "in” and blood “out” lines had Hoffman clamps attached to control the occlusion of the blood lines. Occlusions were set so that at a blood pump speed of 300 ml/min, the "arterial” and "venous” pressures were normalized.
- the dialysis machine was programmed to remove 1000 ml of fluid from the "patient” in a 30 minute “treatment” time. This is the equivalent of an ultrafiltration rate of 2.0 kg/hr.
- a second mock dialysis treatment was conducted with the filter inlet compartment about half full of air to determine if the reduced functional surface area would cause any "treatment” related problems.
- the same filter was used as in the first "treatment”.
- the parameters were identical to those used in the first "treatment”.
- dialysate filters were installed on a test bench containing a 50-liter container of correctly proportioned bicarbonate-based dialysate. Using Tygon tubing segments and appropriate connectors, each filter was connected to a roller pump that drew dialysate out of the container, pushed it through the filter, and returned dialysate filtrate back into the container at a constant flow rate of 800 ml/min.
- Dialysate flow rates can vary from 500-1,000 ml/min, however, typically they do not exceed 600 ml/min.
- Bacterial load in the 50-liter container varied from 10 cfu/ml at the start of the study to 300 cfu/ml at the end of the study.
- Post-filter samples for each filter and the 50-liter container were sampled periodically during the test and after 18 days of dialysate recirculation and throughput. Collection of dialysate container samples was accomplished by using a sterile 25 ml pipette to transfer at least 100 ml of dialysate from the container into a sterile collection bottle. Collection of post-filter samples was accomplished by using a "clean catch" method. The downstream tubing connector was removed from the filter and dialysate was allowed to run out of the outlet port for about 5 seconds. A sterile collection bottle was placed under the stream and at least 100 ml of solution was collected.
- Collection bottle contents were filtered through a 0.2 .[.um.]. .Iadd. ⁇ m .Iaddend.Nalgene disposable filter.
- Sterile forceps were used to transfer the membrane portion .[.df.]. .Iadd.of .Iaddend.the filter onto Tryptic soy agar (TSA) for determination of cfu/ml.
- TSA Plates were incubated at 37° C. for 48 hours.
- a single filter as described in Example 8 was removed from its package and installed on a Travenol 450 SPS dialysis machine, between the lines normally used as dialysate-inflow and dialysate-outflow for the dialysate compartment on a hemodialyzer during dialysis. Properly proportioned bicarbonate-based 37° C. dialysate throughput was initiated and maintained at 600 ml/min.
- the Travenol machine Prior to installation of the dialysate filter, the Travenol machine had been treated with 250 ml of Renalin® Concentrate diluted within the dialysis machine 1:8 in RO water and allowed to dwell within the machine for 30 minutes. After this time, the machine was allowed to rinse until peracetic acid test strips indicated ⁇ 1 ppm in the drain line. Peroxide levels from the Renalin® were also verified ⁇ 1 ppm in filter outlet samples as detected by using a Spectrophotometer.
- TSA Tryptic soy agar
- dialysate filters as described in Example 8 were installed on separate Travenol 450 SPS dialysis machines and left attached between the dialysate-inflow and dialysate-outflow lines. Each filter was exposed to over 600 liters of throughput, 500 liters of which were properly proportioned final bicarbonate-based dialysate, the remainder being RO water. The throughput flow rate was 600 ml/min.
- each Travenol machine Prior to initiating the bacterial challenge, each Travenol machine had been treated with 250 ml of Renalin® Concentrate diluted within the dialysis machine 1:8 in RO water and allowed to dwell within the machine for 30 minutes. After this time, the machine was allowed to rinse until peracetic acid test strips indicated ⁇ 1 ppm in the drain line. Peroxide levels from the Renalin® were also verified ⁇ 1 ppm in filter outlet samples as detected by using a Spectrophotometer.
- TSA Tryptic soy agar
- ETO'd dialysate filters as described in Example 8 were challenged to verify retention of Pseudomonas aeruginosa endotoxin in final dialysate at flowrates of 500-1,000 ml/min.
- LPS lipopolysaccharide
- the pre- and post-filter ports Prior to starting the test, the pre- and post-filter ports, with no filter in-line, were sampled to verify pyrogen-free status. Ports were checked again, with filter in-line, before administering the endotoxin challenge to verify that the filter was clean and that the test setup did not become contaminated during the installation of the filter.
- the gel-clot method of Limulus Amebocyte Lysate endotoxin assaying was used to analyze all samples for presence, absence, or quantification of endotoxin. Additional test conditions included the following:
- Example 17 The test setup used in Example 17 was also used for this test series. The most noteworthy differences between Example 17 and this example include the following:
- RO water was used instead of final bicarbonate-based dialysate.
- the first two filters were challenged using endotoxin derived from Escherichia coli.
- the last four were challenged with Pseudomonas aeruginosa LPS.
- the last five filters tested had LPS delivered into the dialysate by using a metered syringe pump with a glass syringe.
- the concentrated, reconstituted LPS was drawn up into the syringe and a line attached to the filter inlet tubing.
- the syringe pump injected endotoxin at a controlled rate from the syringe directly into the filter inlet stream.
- pre- and post-filter ports Prior to starting the test, pre- and post-filter ports, with no filter in-line, were sampled to verify pyrogen-free status of the test setup. Ports were checked again, with filter in-line, before administering the endotoxin challenge to verify that the filter was clean and that the test setup did not become contaminated during the installation of the filter.
- Filters received endotoxin challenges varying in potency from ⁇ 15 EU/ml up to 48 EU/ml; of either Escherichia coli or Pseudomonas aeruginosa endotoxin at RO water throughput flowrates of 2,000 ml/min. Each filter retained all endotoxin contained within the challenge solution. No detectable endotoxin is reported as ⁇ 0.06 EU/ml, the limit of sensitivity for the Lysate used in the assay. (See Table below for details.)
- filters were run 24 hours/day on a recirculation setup with contaminated dialysate. Shedding only occurs in filters that have not been periodically re-sterilized during use (every 24-48 hours).
- This "recirculation" setup included a 50-liter container of final bicarbonate-based dialysate, a roller pump, and connecting tubing with Hansen-style connectors for attachment to filter .[.in-lets.]. .Iadd.inlets .Iaddend.and outlets.
- the roller pump moved dialysate up to the pump, through the filters, and returned the dialysate filtrate back into the 50-liter container.
- This setup provided throughput of 800 ml/min, 24 hours/day for each filter.
- the dialysate was deliberately not disinfected so that levels of bacteria in the tank would rise over time.
- the membrane disinfection and clearing procedure consisted of the following steps:
- the pre- and post-filter ports Prior to starting the test, the pre- and post-filter ports, with no filter in-line, were sampled to verify non-pyrogenic status. Ports were checked again, with filter in-line, before administering the endotoxin challenge to verify that the filter was clean and that the test setup did not become contaminated during the installation of the filter.
- LPS lipopolysaccharide
- Filters were exposed to recirculating dialysate throughput flowrates of 800 ml/min, 24 hours/day until the transmembrane pressure drop had doubled. Within this highly exaggerated test condition, the filters began to "shed” LAL-reactive material. Filters were then subjected to a Renalin® membrane clearing and disinfecting procedure.
- the outlet header cap of a filter as described in Example 8 was contaminated with 0.1 ml of a 10 10 cfu/ml suspension Bacillus subtilis spores, 25 ml of Renalin® Cold Sterilant Concentrate was then injected into the filter for a 12 hour dwell period and viability of the spores was checked.
- a dialysate filter representative of final sterilized product, was installed on a Travenol 450 SPS dialysis machine between the dialyzer-in and dialyzer-out dialysate lines. Flow was initiated through the filter at 600 ml/min and the machine was connected to bicarbonate and acid electrolyte solutions. The machine was allowed to proportion final dialysate until 37° C. temperature and 13.8 mS/cm solution conductivity was obtained (normal final dialysate parameters).
- the dialysis machine was turned off and 25 ml of Renalin® Cold Sterilant Concentrate was injected into the Luer port provided on the filter.
- the outlet header coupler was then disconnected and 0.1 ml of a 10 10 cfu/ml Bacillus subtilis bacterial endospore suspension was pipetted into the header cap.
- the filter was left installed in the dialysate lines on the dialysis machine, with the Renalin® dwelling for about 16 hours.
- the filter unit was removed from the dialysis machine and the fluid it contained was drained into a sterile collection bottle. It was then re-attached to the dialysis machine and the machine turned on to flush another 100 ml out through the unit.
- the end volume in the collection bottle was about 200 ml.
- a suspension containing 10 10 Bacillus subtilis bacterial endospores were injected into the fluid inlet stream of four filters as described in Example 8, driving the spores against the filter membrane.
- each of the four filters to be used in the sporicidal Renalin® treatment test was installed one-at-a-time on a Travenol 450 SPS dialysis machine between the dialyzer-in and dialyzer-out dialysate lines.
- RO water flow was initiated through each filter at 600 ml/min.
- One ml containing 10 10 spores was injected into the filter's inlet stream and the machine was allowed to run for another 5 minutes to drive the spores against the membrane.
- the machine was turned off and 10 ml of Renalin® Concentrate was injected into the Luer port on each filter.
- the filters remained installed on the dialysis machine for a minimum of six hours.
- Renalin® Cold Sterilant Concentrate injected into the 85 ml fluid volume of the filter, yields an effective Renalin® concentration of ⁇ 1% (about 2.8% hydrogen peroxide within the filter).
- Filtrate was then passed through a sterile 0.2 ⁇ m Nalgene analytical filter, followed by at least 90 ml of the "neutralizing rinse" used in the previous test.
- the neutralizing rinse was then followed by at least 100 ml of sterile DI water.
- the analytical membrane filter was then moved with a sterile forceps onto a TSA plate and allowed to incubate for at least 48 hours at 37° C. If any growth was present, a Gram stain was done to help determine if the colony was the same as the inoculating .[.organis.]. .Iadd.organism .Iaddend.(Bacillus Subtilis).
- filter#1's test solution had one colony forming unit. A Gram stain was done on the colony and it was found to be Gram positive Staphylococci, not the inoculating organism. This is probably due to contamination during setup or collection. Therefore, in the Table below, the result was recorded as "no growth". The other three filters' test solutions were all negative for any growth.
- the outlet header cap of a filter as described in Example 8 was contaminated with 0.1 ml of a 10 10 cfu/ml suspension Bacillus subtilis spores, and then injected with 25 ml of Renalin® Cold Sterilant Concentrate to check the viability of spores after twelve (12) hours.
- An ETO'd dialysate filter was installed on a Travenol 450 SPS dialysis machine between the dialyzer-in and dialyzer-out dialysate lines. Flow was initiated through the filter at 600 ml/min and the machine was connected to bicarbonate and acid electrolyte solutions. The machine was allowed to proportion final dialysate until 37° C. temperature and 13.8 mS/cm solution conductivity was obtained (normal final dialysate parameters).
- the dialysis machine was turned off and 25 ml of Renalin® Cold Sterilant Concentrate was injected into the Luer port provided on the filter.
- the outlet header coupler was then disconnected and 0.1 ml of a 10 10 cfu/ml Bacillus subtilis bacterial endospore suspension was pipetted into the header cap.
- the filter was left installed in the dialysate lines on the dialysis machine, with the Renalin® indwelling for about 12 hours.
- the filter unit was removed from the dialysis machine and the fluid it contained was drained into a sterile collection bottle. It was then re-attached to the dialysis machine and the machine turned on to flush another 100 ml out through the unit.
- the end volume in the collection bottle was about 200 ml.
- RenaGuard® Dialysate Filters Four (4) prototype RenaGuard® Dialysate Filters, were injected with a suspension containing 10 10 Bacillus subtilis bacterial endospores into each filter's fluid inlet stream, driving them against the filter membrane. 10-25 ml of Renalin® Cold Sterilant Concentrate was injected into the filter, and the viability of the spores was checked after six to twelve hours.
- each of the four filters to be used in the sporicidal Renalin® treatment test was installed one-at-a-time on a Travenol 450 SPS dialysis machine between the dialyzer-in and dialyzer-out dialysate lines.
- RO water flow was initiated through each filter at 600 ml/min.
- One ml of spore suspension was injected into the filter's inlet stream and the machine was allowed to run for another 5 minutes to drive the spores against the membrane.
- the machine was turned off and Renalin® Concentrate was injected into the Luer port on each filter.
- the filters remained installed on the dialysis machine for a minimum of six hours with Renalin® indwelling.
- Filtrate was then passed through a sterile 0.2 ⁇ m Nalgene analytical filter, followed by at least 90 ml of the "neutralizing rinse" used in the previous test.
- the neutralizing rinse was then followed by at least 100 ml of sterile DI water.
- the analytical membrane filter was then moved with a sterile forceps onto a TSA plate and allowed to incubate for at least 48 hours at 37° C. If any growth was present, a Gram stain was done to help determine if the colony was the same as the inoculating organism (Bacillus subtilis).
- filter#1's test solution had one colony growing. A Gram stain was done on the colony and it was found to be Gram positive Staphylococci, not the inoculating organism. .[.Result.]. .Iadd.The result was .Iaddend.recorded as "no growth". The other three filters' test solutions were all negative for any growth.
- a filter as described in Example 8 was challanged by exposing it to three back-to-back 85° C. heat disinfection treatments using a Fresenius A2008H dialysis machine. The filter's endotoxin retention capability was evaluated after exposure.
- a dialysate filter was installed on a Fresenius A2008H dialysis machine between the dialyzer-in and dialyzer-out dialysate lines.
- the dialysis machine was turned on and the heat disinfection cycle was initiated. Upon completion of this cycle, it was immediately re-initiated two more times.
- the filter was removed from the machine and installed on a test bench for delivering an endotoxin challenge into the filter's inlet stream.
- DI water throughput was initiated at 500 ml/min and continued for the duration of the test.
- Endotoxin derived from Escherichia coli was introduced into the filter's inlet stream at 15.4 EU/ml. Filtrate endotoxin levels were measured using the gel-clot method of Limulus Amebocyte Lysate endotoxin assaying.
- Filter inlet and outlet pressures were also measured and compared to values recorded prior to heat treatments.
- Filters as described in Example 8 were exposed to exaggerated bleach contact conditions using a COBE Centry 2Rx or Travenol 450 SPS dialysis machine. The filters were re-evaluated for endotoxin retention capability after exposure.
- Two filters were exposed to approximately 30 days' worth of bleach treatments. Both filters were given six exposures of 1,250 ml each, with a 5 minute rinse between each exposure. The dilution level was 1:8 bleach in RO water. The dilution was accomplished by using a COBE Centry 2Rx dialysis machine. The total bleach contact time was 2 hours and 5 minutes. The filters were installed on the dialysis machine and the bleaching procedure followed right out of the COBE Centry 2Rx Operator's manual. The only exception was that 7,500 ml of bleach was used instead of the 250 ml specified in the procedure.
- DI water throughput was initiated at 500 ml/min and continued for the duration of the test.
- Endotoxin derived from Escherichia .[.coil.]. .Iadd.coli .Iaddend. was introduced into the filter's inlet stream at ⁇ 3.8 EU/ml. Filtrate endotoxin levels were measured using the gel-clot method of Limulus Amebocyte Lysate endotoxin assaying.
- Filter inlet and outlet pressures were also measured and compared to values recorded prior to bleach treatments.
- the first filter exposed to bicarbonate dialysate throughput and eight 20 cc bleach injections, was challenged with ⁇ 7.7 EU/ml level of Escherichia coli endotoxin. No endotoxin was detected in filter outlet samples at 5, 30, and 60 minutes.
- the second filter exposed to acetate dialysate throughput and eight 20 cc bleach injections, was challenged with ⁇ 7.7 EU/ml level of Escherichia coli endotoxin. No endotoxin was detected in filter outlet samples at 5, 30, and 60 minutes.
- the third filter exposed to RO water throughput and eight 20 cc bleach injections, was challenged with ⁇ 7.7 EU/ml level of Escherichia coli endotoxin. No endotoxin was detected in filter outlet samples at 5, 30, and 60 minutes.
- the fourth filter exposed to 30 days' worth of bleach treatments, was challenged with ⁇ 3.8 EU/ml level of Escherichia coli endotoxin. No endotoxin was detected in filter outlet samples at 1, 3, and 5 minutes.
- the fifth filter exposed to 30 days' worth of bleach treatments, was challenged with ⁇ 15.4 EU/ml level of Escherichia coli endotoxin. No endotoxin was detected in filter outlet samples at 1, 3, and 5 minutes.
- a filter as described in Example 8 was exposed to 30 days' worth of Actril® disinfection treatments using a Travenol 450 SPS dialysis machine. The filters' endotoxin retention capability after exposure was reevaluated.
- One filter was exposed to approximately 30 days' worth of Actril® treatments.
- the filter was given six exposures of 1,250 ml each, with a 5 minute rinse between each exposure.
- the dilution level was 1:8 Actril® in RO water.
- the dilution was accomplished by using a COBE Centry 2Rx dialysis machine.
- the total Actril® contact time was 2 hours and 5 minutes.
- the filter was installed on the dialysis machine and the procedure followed right out of the COBE Centry 2Rx Operator's manual. The only exceptions were that 7,500 ml of chemical was used instead of the 250 ml specified in the procedure, and, Actril® was used instead of bleach.
- the filter was rinsed with DI water on the dialysis machine until ⁇ 1 ppm of hydrogen peroxide was detected using Renalin® residual test strips (for hydrogen peroxide, not peracetic acid).
- the filters was then installed on a test bench for administering the endotoxin challenge, identical to the one used in Example 24.
- DI water throughput was initiated at 500 ml/min and continued for the duration of the test.
- Endotoxin derived from Escherichia coli was introduced into the filter's inlet stream at ⁇ 15.4 EU/ml. Filtrate endotoxin levels were measured using the gel-clot method of Limulus Amebocyte Lysate endotoxin assaying.
- Filter inlet and outlet pressures were also measured and compared to values recorded prior to bleach treatments.
- a filter as described in Example 8 was exposed to Renalin® contact conditions using a Travenol 450 SPS dialysis machine. The filter's endotoxin retention capability after exposure was reevaluated.
- filters were run 24 hours/day at 800 ml/min on a recirculation setup with contaminated dialysate.
- Shedding only occurs in filters that have not been periodically re-sterilized during use (every 24-48 hours).
- the Renalin® membrane disinfection and clearing procedure consisted of the following steps:
- LPS lipopolysaccharide
- a filter as described in Example 8 was exposed to an amount of bleach contact consistent with normal dialysis machine "low-level” disinfection, and, a clearance curve (ppm vs. time) of residual free chlorine levels during 500 ml/min RO water throughput was plotted.
- a dialysate filter was installed on a COBE Centry 2 Rx dialysis machine, and a bleach treatment was performed as described in the COBE Centry 2Rx Operator's Handbook.
- This treatment consisted of an exposure to a 1:8 dilution bleach (0.65% sodium hypochlorite) in water solution while the filter was installed on the dialysis machine.
- Free chlorine residuals rinsed from the filter down to 1.6 ppm within 10 minutes at a 470 ml/min RO water throughput flow rate.
- a filter as described in Example 8 was exposed to an amount of Actril® contact consistent with normal dialysis machine "low-level” disinfection, and, a clearance curve (ppm vs. time) of residual hydrogen peroxide levels during 500 ml/min RO water throughput was plotted.
- a dialysate filter was installed on a COBE Centry 2 Rx dialysis machine, and a chemical treatment was performed as described in the COBE Centry 2Rx Operator's Handbook, substituting Actril® for bleach as the chemical used.
- This treatment consisted of an exposure to a 1:8 dilution Actril® (0.1% hydrogen peroxide) in water solution while the filter was installed on the dialysis machine.
- Hydrogen peroxide residuals rinsed from the filter down to 0.6 ppm within 10 minutes at a 470 ml/min RO water throughput flow rate.
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- Health & Medical Sciences (AREA)
- Urology & Nephrology (AREA)
- Engineering & Computer Science (AREA)
- Water Supply & Treatment (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
- External Artificial Organs (AREA)
Abstract
Description
TABLE I ______________________________________ More Most Preferred Preferred Preferred ______________________________________ Solvent with 50-99 wt. % 60-95 wt. % 75-90 wt. % respect to polymer Water 35-1 wt. % 30-5 wt. % 20-10 wt. % Add'l Non-Solvents 15-0 wt. % 10-0 wt. % 5-0 wt. % with respect to polymer ______________________________________
TABLE II ______________________________________ Fiber Hydrophilic Polymer Number of Fibers 5000 Effective Surface Area 0.3 m.sup.2 Initial Pressure drop 60 mmHg (in dialysate) (Q = 500 ml/min) Maximum Pressure Drop 160 mmHg (in dialysate) Total Fluid Volume 72 ml Overall Unit Length 192 mm Unit Weight (Dry) 145 g Outer Case Material Polycarbonate Potting Compound Polyurethane O-Ring Silicone Dialysis Fluid Connectors Hansen or Walther Connectors ______________________________________
______________________________________ Phos- Cytochrome Blood Fl. Urea Creatinine phorous B-12 C ______________________________________ 200 mL/m 179.4 164.9 156.5 87.4 129.9 300 mL/m 225.0 198.5 182.6 93.8 143.0 400 mL/m 244.8 212.5 208.7 95.7 146.8 ______________________________________
______________________________________ Phos- Cytochrome Blood Fl. Urea Creatinine phorous B-12 C ______________________________________ 200 mL/m 188.1 178.3 166.7 88.5 156.9 300 mL/m 249.6 223.4 212.5 95.4 178.7 400 mL/m 281.5 246.7 233.5 116.0 184.0 ______________________________________
______________________________________ Phos- Cytochrome Blood Fl. Urea Creatinine phorous B-12 C ______________________________________ 200 mL/m 190.7 178.4 166.7 -- 162.9 300 mL/m 255.2 232.45 228.0 -- 185.7 400 mL/m 287.3 256.9 240.0 -- 188.8 ______________________________________
TABLE III ______________________________________ Fiber Hydrophilic Polymer Number of Fibers 5000 Effective Surface Area 0.3 m.sup.2 Initial Pressure drop 60 mmHg (in dialysate) (Q = 500 ml/min) Maximum Pressure Drop 160 mmHg (in dialysate) Total Fluid Volume 72 ml Overall Unit Length 192 mm Unit Weight (Dry) 145 g Outer Case Material Polycarbonate Potting Compound Polyurethane O-Ring Silicone Dialysis Fluid Connectors Hansen or Walther Connectors ______________________________________
TABLE IV ______________________________________ Dialysate Within Analyte Unfiltered Filtered ±2% VAR VAriance ______________________________________ Sodium 135 mEq/L 133 mEq/L 132.3- Yes 137.7 Potassium 1.9 mEq/L 1.9 mEq/L 1.86-1.94 Yes Chloride 102 mEq/L 100 mEq/L 99.9- Yes 104.0 Calcium 6.8 mg/dl 6.8 mg/dl 6.6-6.94 Yes Magne- 1.2 mEq/L 1.2 mEq/L 0.000.00 Yes sium Aluminum 0.099 mg/L 0.100 mg/L 0.097- Yes 0.101 Copper <0.002 mg/L <0.002 mg/L 0.00 Yes Selenium <0.050 mg/L <0.050 mg/L 0.00 Yes Zinc 0.006 mg/L 0.006 mg/L 0.00 Yes Chromium <0.005 mg/L <0.005 mg/L 0.00 Yes Lead <0.001 mg/L <0.001 mg/L 0.00 Yes Arsenic <0.002 mg/L <0.002 mg/L 0.00 Yes Mercury <0.0002 mg/L <0.0002 mg/L 0.00 Yes Cadmium <0.001 mg/L <0.001 mg/L 0.00 Yes Fluoride <0.10 mg/L <0.10 mg/L 0.00 Yes Nitrate <0.2 mg/L <0.2 mg/L 0.00 Yes Sulfate 1.0 mg/L 1.0 mg/L 0.00 Yes Silver <0.003 mg/L <0.003 mg/L 0.00 Yes Barium 0.002 mg/L 0.002 mg/L 0.00 Yes ______________________________________ **concentration variance of 2%.
TABLE V ______________________________________ Change in Throughput Solution Resistivity Due to Filters T = 0 Minutes T = 30 Minutes Average Inlet Water Filtrate Filtrate Filtrate Resistivity, Resistivity, Resistivity, Resistivity, Filter # Megohm-cm Megohm-cm Megohm-cm Megohm-cm ______________________________________ 1.00 15.38 7.00 5.70 6.25 2.00 14.55 5.63 5.30 5.48 AVG 15.10 6.32 5.50 5.90 ______________________________________
TABLE VI ______________________________________ Sample cfu/ml ______________________________________ T = 0 Pre-filter 1 T = 0 Post-filter 0 T = 0 Bicarb jug 1.8 × 10.sup.7 T = 5 Pre-filter 1.6 × 10.sup.7 T = 5 Post-filter 0 T = 30 Pre-filter 1.9 × 10.sup.7 T = 30 Post-filter 0 T = 60 Pre-filter 1.9 × 10.sup.7 T = 60 Post-filter 0 ______________________________________
TABLE VII ______________________________________ Filter #1, After 2 days Sample cfu/ml ______________________________________ T = 0 Pre-filter 147 T = 0 Post-filter 2 T = 0 Bicarb jug 1.5 × 10.sup.6 T = 5 Pre-filter 2.5 × 10.sup.5 T = 5 Post-filter 0 T = 30 Pre-filter 2.1 × 10.sup.5 T = 30 Post-filter 0 T = 60 Pre-filter 2.2 × 10.sup.5 T = 60 Post-filter 1 ______________________________________
TABLE VIII ______________________________________Filter # 2, After 3 days Sample cfu/ml ______________________________________ T = 0 Pre-filter 319 T = 0 Post-filter 0 T = 0 Bicarb jug 4.7 × 10.sup.5 T = 5 Pre-filter 3.6 × 10.sup.4 T = 5 Post-filter 33 T = 30 Pre-filter 4.7 × 10.sup.4 T = 30 Post-filter 1 T = 60 Pre-filter 3.7 × 10.sup.4 T = 60 Post-filter 1 ______________________________________
TABLE IX ______________________________________ Pseudomonas aeruginosa Dialysate Endotoxin Challenge Endotoxin Challenge Endotoxin Filtrate Filter Level, Level, EU/ml Treatment # EU/ml 1MIN 3MIN 5 MIN conditions ______________________________________ 1 6 <0.06 <0.06 <0.06 Also DI water, 48 EU/ml in, <0.06 EU/ml in alloutlet samples 2 6 <0.06 <0.06 <0.06 -- 3 12 <0.06 <0.06 <0.06 Pseudomonas LPS sonicated & vortexed prior touse 4 60 <0.06 <0.06 <0.06 Pseudomonas LPS sonicated & vortexed prior touse 5 12 <0.06 <0.06 <0.06 800 ml/min throughput flowrate 6 24 <0.06 <0.06 <0.06 Run on dialysis machine, 600 ml/min LPS introduced into water inlet 7 4.8 <0.06 <0.06 <0.06 Pre-treated with 10 Renatron ® cycles 8 6 <0.06 <0.06 <0.06 Also 1,000 ml/min throughput flowrate, 12 EU/ml inlet, <0.06 EU/ml outlets ______________________________________
TABLE X ______________________________________ Syringe Pump Endotoxin Challenge at 2,000 ml/min Endotoxin Endotoxin Challenge Filtrate Filter Level, Level, EU/ml # EU/ml 1MIN 4 MIN Treatment conditions ______________________________________ 1 48 <0.06 <0.06 E. Coli LPS, contaminated RO water in 21/2gallon jug 2 24 <0.06 <0.06 E. Coli LPS,Syringe pump administration 3 ≧15 <0.06 <0.06 P. aeruginosa LPS,Syringe pump administration 4 ≧15 <0.06 <0.06 P. aeruginosa LPS,Syringe pump administration 5 ≧15 <0.06 <0.06 P. aeruginosa LPS,Syringe pump administratoin 6 ≧15 <0.06 <0.06 P. aeruginosa LPS, Syringe pump administration ______________________________________
TABLE XI ______________________________________ Recovery of Endotoxin Retention After Renalin ® Exposure "Shedding" LAL- reactive Endotoxin Material Challenge before Level, Endotoxin Filtrate Renalin ® EU/Ml Level, EU/ml Filter Treatment Treatment ? (After 1 3 5 # conditions (Y/N) Renalin ®) MIN MIN MIN ______________________________________ 1 20,000 liters Yes, 15.4 <0.06 <0.06 <0.06 recirculated >0.06 EU/Ml dialysate, then Renalin ® treated 2 20,000 liters Yes, 15.4 <0.06 <0.06 <0.06 recirculated >0.06 EU/Ml dialysate, then Renalin ® treated 3 20,000 liters Yes, 7.7 <0.06 <0.06 <0.06 recirculated >0.06 EU/Ml dialysate, then Renalin ® treated 4 20,000 liters Yes, 30.7 <0.06 <0.06 <0.06 recirculated >0.06 EU/Ml dialysate, then Renalin ® treated ______________________________________
TABLE XII ______________________________________ Number Post- of Treatment Spores Dwell Incubation Spores Filter Injected Renalin ® Time, Period, Viable, # Total Used, ml hours hours cfu/ml ______________________________________ 1 10 Billion 25 12 48 0 2 10 Billion 20 6 72 0 3 10 Billion 10 6.5 48 0 4 10 Billion 10 6 48 0 ______________________________________
TABLE XIII ______________________________________ Number Post- of Treatment Spores Dwell Incubation Spores Filter Injected Renalin ® Time, Period, Viable, # Total Used, ml hours hours cfu/ml ______________________________________ 1 100Billion 25 12 48 0 2 100 Billion 20 6 72 0 3 100 Billion 10 6.5 48 0 4 100 Billion 10 6 48 0 ______________________________________
TABLE XIV ______________________________________ Endotoxin Filtrate Challenge Endoroxin Filter # Pre-treat Conditions Level Level ______________________________________ 1 Eight injections of 20 cc 7.7 EU/ml <0.06 EU/ml bleach delivered duringbicarbonate throughput 2 Eight injections of 20 cc 7.7 EU/ml <0.06 EU/ml bleach delivered duringbicarbonate throughput 3 Eight injections of 20 cc 7.7 EU/ml <0.06 EU/ml bleach delivered duringRO water throughput 4 30 Days' worth of 3.8 EU/ml <0.06 EU/ml bleach treatments 5 30 Days' worth of 15.4 EU/ml <0.06 EU/ml bleach treatments ______________________________________
TABLE XV ______________________________________ Recovery of Endotoxin Retention After Renalin ® Exposure "Shedding" LAL- reactive Endotoxin Material Challenge before Level, Endotoxin Filtrate Renalin ® EU/Ml Level, EU/ml Filter Treatment Treatment ? (After 1 3 5 # conditions (Y/N) Renalin ®) MIN MIN MIN ______________________________________ 1 20,000 liters Yes, 15.4 <0.06 <0.06 <0.06 recirculated >0.06 EU/ml dialysate, then Renalin ® treated 2 20,000 liters Yes, 15.4 <0.06 <0.06 <0.06 recirculated >0.06 EU/ml dialysate, then Renalin ® treated 3 20,000 liters Yes, 7.7 <0.06 <0.06 <0.06 recirculated >0.06 EU/ml dialysate, then Renalin ® treated 4 20,000 liters Yes, 30.7 <0.06 <0.06 <0.06 recirculated >0.06 EU/ml dialysate, then Renalin ® treated ______________________________________
Claims (30)
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US08/058,904 US5762798A (en) | 1991-04-12 | 1993-05-06 | Hollow fiber membranes and method of manufacture |
US08/418,802 US5605627A (en) | 1992-10-07 | 1995-04-07 | Dialysate filter including an asymmetric microporous, hollow fiber membrane incorporating a polyimide |
US09/250,449 USRE36914E (en) | 1992-10-07 | 1999-02-16 | Dialysate filter including an asymmetric microporous, hollow fiber membrane incorporating a polyimide |
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US08/418,802 Reissue US5605627A (en) | 1992-10-07 | 1995-04-07 | Dialysate filter including an asymmetric microporous, hollow fiber membrane incorporating a polyimide |
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