WO2002043859A2 - Cartridges useful in cleaning dialysis solutions - Google Patents
Cartridges useful in cleaning dialysis solutions Download PDFInfo
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- WO2002043859A2 WO2002043859A2 PCT/US2001/044660 US0144660W WO0243859A2 WO 2002043859 A2 WO2002043859 A2 WO 2002043859A2 US 0144660 W US0144660 W US 0144660W WO 0243859 A2 WO0243859 A2 WO 0243859A2
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- sorbent cartridge
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- present
- carbonate
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/02—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material
- B01J20/04—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material comprising compounds of alkali metals, alkaline earth metals or magnesium
- B01J20/043—Carbonates or bicarbonates, e.g. limestone, dolomite, aragonite
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1694—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes with recirculating dialysing liquid
- A61M1/1696—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes with recirculating dialysing liquid with dialysate regeneration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/02—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material
- B01J20/0203—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material comprising compounds of metals not provided for in B01J20/04
- B01J20/0211—Compounds of Ti, Zr, Hf
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/02—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material
- B01J20/0203—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material comprising compounds of metals not provided for in B01J20/04
- B01J20/0274—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material comprising compounds of metals not provided for in B01J20/04 characterised by the type of anion
- B01J20/0277—Carbonates of compounds other than those provided for in B01J20/043
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/02—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material
- B01J20/0203—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material comprising compounds of metals not provided for in B01J20/04
- B01J20/0274—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material comprising compounds of metals not provided for in B01J20/04 characterised by the type of anion
- B01J20/0292—Phosphates of compounds other than those provided for in B01J20/048
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/02—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material
- B01J20/06—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material comprising oxides or hydroxides of metals not provided for in group B01J20/04
- B01J20/08—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material comprising oxides or hydroxides of metals not provided for in group B01J20/04 comprising aluminium oxide or hydroxide; comprising bauxite
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/02—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material
- B01J20/20—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material comprising free carbon; comprising carbon obtained by carbonising processes
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/28—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof characterised by their form or physical properties
- B01J20/28014—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof characterised by their form or physical properties characterised by their form
- B01J20/28052—Several layers of identical or different sorbents stacked in a housing, e.g. in a column
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/30—Processes for preparing, regenerating, or reactivating
- B01J20/32—Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating
- B01J20/3231—Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating characterised by the coating or impregnating layer
- B01J20/3234—Inorganic material layers
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- C—CHEMISTRY; METALLURGY
- C01—INORGANIC CHEMISTRY
- C01G—COMPOUNDS CONTAINING METALS NOT COVERED BY SUBCLASSES C01D OR C01F
- C01G25/00—Compounds of zirconium
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- C—CHEMISTRY; METALLURGY
- C01—INORGANIC CHEMISTRY
- C01G—COMPOUNDS CONTAINING METALS NOT COVERED BY SUBCLASSES C01D OR C01F
- C01G25/00—Compounds of zirconium
- C01G25/006—Compounds containing, besides zirconium, two or more other elements, with the exception of oxygen or hydrogen
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J2220/00—Aspects relating to sorbent materials
- B01J2220/40—Aspects relating to the composition of sorbent or filter aid materials
- B01J2220/42—Materials comprising a mixture of inorganic materials
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J2220/00—Aspects relating to sorbent materials
- B01J2220/50—Aspects relating to the use of sorbent or filter aid materials
- B01J2220/62—In a cartridge
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- C—CHEMISTRY; METALLURGY
- C01—INORGANIC CHEMISTRY
- C01P—INDEXING SCHEME RELATING TO STRUCTURAL AND PHYSICAL ASPECTS OF SOLID INORGANIC COMPOUNDS
- C01P2004/00—Particle morphology
- C01P2004/60—Particles characterised by their size
- C01P2004/61—Micrometer sized, i.e. from 1-100 micrometer
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- C—CHEMISTRY; METALLURGY
- C01—INORGANIC CHEMISTRY
- C01P—INDEXING SCHEME RELATING TO STRUCTURAL AND PHYSICAL ASPECTS OF SOLID INORGANIC COMPOUNDS
- C01P2006/00—Physical properties of inorganic compounds
- C01P2006/80—Compositional purity
- C01P2006/82—Compositional purity water content
Definitions
- the present invention relates to cartridges such as ion exchange cartridges or adsorption cartridges which are useful, for instance, in dialysis.
- the present invention relates in general to the regeneration or purification of used dialysate fluids.
- the present invention further relates to methods of conducting dialysis using certain cartridges and also relates to methods of making the cartridges.
- Dialysis is a treatment that removes the waste products and excess fluid that accumulate in the blood as a result of kidney failure.
- Chronic renal failure is when the renal function has deteriorated to about 25% of normal. This amount of deterioration causes significant changes in the blood chemistry and is about the time that people feel poorly enough that they seek medical care. If medical treatment is sought at that time, progression can be slowed.
- Late stage chronic renal failure is when kidney function has decreased to 15%.
- End stage renal failure is when kidney function is at 5% of normal. Death will most likely result without treatment at this point.
- As of 1998 there were 430,000 patients in the United States diagnosed with chronic renal failure, wherein the average life expectancy of a chronic renal failure patient is 2 l A years. Some do live 20 years or more.
- the membrane allows the wastes, electrolytes, and water to cross but restricts the passage of large molecular weight proteins and blood cells.
- Blood is pumped across one side of the membrane as dialysate is pumped in the opposite direction across the other side of the membrane.
- the dialysate is highly purified water with salts and electrolytes added.
- the machine is a control unit which acts to pump and control pressures, temperatures, and electrolyte concentrations of the blood and the dialysate.
- the average length of one hemodialysis treatment is 3-5 hours.
- hemodialysis There are several types of hemodialysis: a) Single Pass - hemodialysis is the most common treatment for renal disease. Most hemodialysis treatments are performed with single pass dialysis machines. They are called single pass because the dialysate (cleaning solution) passes by the blood in the dialyzer one time and then is disposed. Single pass dialysis machines generally require:
- a water source capable of delivering at least 1000-1500 ml/min (assuming a 50% rejection rate by the R.O. system) 2) a water purification system sufficient of providing a continuous flow of
- sorbent systems require only a 5 amp electrical source because they recycle the same small volume of dialysate throughout the dialysis procedure.
- the heavy duty dialysate pumps and heaters used for large volumes of dialysate in single pass dialysis are not needed.
- the sorbent system can use 6 liters of tap water from which dialysate is made for an entire treatment.
- the sorbent system uses a sorbent cartridge - which acts both as a water purifier and as a means to regenerate used dialysate into fresh dialysate.
- the infusate system acts with it to properly balance the electrolyte composition of the regenerated dialysate.
- the sorbent cartridge containing zirconium phosphate (ZrP) and hydrous zirconium oxide (HZO) ion-exchange materials has been historically used for the REDY regeneration hemodialysis system.
- the scheme of the REDY cartridge is shown in Figure
- the carbonate from the urea hydrolysis then combines with the hydrogen ions in NaHZrP to form bicarbonate, which is delivered to the uremic patient as a base to correct for acidosis.
- the hydrous zirconium oxide (HZO) containing acetate as a counter ion serves as an anion exchanger to remove phosphate from uremic patients for the treatment of hyperphosphatemia.
- the material also prevents leaching of phosphate from NaHZrP and removes toxic anions (e.g., fluoride) in water that may cause harm to a patient during dialysis.
- the acetate released during ion exchange is also a base to correct for acidosis by acetate metabolism.
- the granular activated carbon in the cartridge is responsible for the removal of creatinine, uric acid, and nitrogenous metabolic waste of the patient as well as chlorine and chloramine from water.
- the REDY regenerative dialysis system is efficient to provide both safety and simplicity of water treatment and hence convenience for hemodialysis.
- the efficacy and safety record of the system has been well established.
- the REDY cartridge can produce a variation of dialysate composition and pH during the treatment with a continuous release of Na + by the cartridge.
- the REDY dialysis therapy has to provide several dialysate prescriptions to balance the Na + level in the patient for the correction of hyper and hyponatremia.
- a conductivity alarm system is generally present to keep the Na + level in the dialysate below a safe limit with proper dilution.
- the Na + and bicarbonate level in the dialysate may vary with the BUN level of the patient.
- peritoneal dialysis In the area of peritoneal dialysis (PD), particular emphasis has to be put on (1) a minimum variation of dialysate composition and pH during the PD treatment and (2) cost and size of the cartridge.
- the adsorption capacity requirement of sorbent PD may be lower than that of REDY cartridge.
- the variation of dialysate composition is particularly important since PD is a slow treatment with treatment duration up to 2-4 hours per day. Excessive donation of Na + by the cartridge to the patient should be avoided during the treatment.
- an understanding of the ion exchange mechanism of ZrP with ammonium ions and dialysate cations (Ca, Mg, K, and Na) is needed.
- ZrP is an inorganic cation exchange material with the molecular structure as shown below:
- H + and Na + as counter-ions, which are responsible for ion exchange.
- the relative content of these ions in ZrP can be controlled by the pH to which acid ZrP (or H + ZrP) is titrated with NaOH.
- the composition of the resultant product of titration, Na x + H 2 . x + ZrP, may vary during the following ion exchange processes in dialysate:
- the relative release of Na + and H + by ZrP during the ion exchange depends on the ion exchange equilibrium of these ions in ZrP with other cations in the liquid phase.
- the equilibrium may shift as the composition of Na + H + ZrP and liquid phase continue to change during the ion exchange process.
- PD treatment is that the hydrous zirconium oxide loaded with acetate is an acidic material.
- a feature of the present invention is to provide materials which are useful in the regeneration or purification of solutions containing waste products.
- the present invention also relates to a sorbent dialysis system comprising a sorbent cartridge, wherein the sorbent cartridge contains at least sodium zirconium carbonate or an alkali metal-Group IV B metal carbonate.
- the system can be a single pass dialysis system or a sorbent dialysis system.
- This system with respect to a sorbent dialysis system further preferably contains an infusate pump, a dialyzer, a pump, and a reservoir all interconnected in an operating system as shown for instance in Figure 2. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are intended to provide a further explanation of the present invention, as claimed.
- Figures 4-6 are exploded views of preferred materials in sorbent cartridges of the present invention.
- the present invention relates to materials useful for separation processes such as the removal of waste products and excess fluid that accumulates in dialysate fluids. These materials are preferably present in a container (i.e., a cartridge) capable of holding the materials useful for the separation process.
- a container i.e., a cartridge
- the materials described in detail below or the arrangement of various materials are preferably used in a dialysis system or other similar type of system that is useful for the removal of waste products and/or excess fluid that accumulates in dialysate fluids, for instance, as a result of conducting dialysis.
- a dialysis solution means a peritoneal dialysis solution or dialysate fluids that are useful in hemodialysis or sorbent dialysis systems.
- Conventional dialysis solutions for PD or HD can be used and regenerated by the present invention and are known to those skilled in the art.
- the present invention relates to a sorbent cartridge that contains at least an alkali metal-Group IV B metal carbonate.
- Group IV B is with reference to a column in the Periodic Table.
- the Group IV B metal are titanium, zirconium, and hafnium.
- the Group IV B metal is zirconium and therefore the preferred material in the sorbent cartridge is sodium zirconium carbonate.
- Any type of alkali metal-Group IV B metal carbonate can be used as long as the alkali metal-Group IV B metal carbonate is preferably capable of acting as a phosphate adsorbent.
- the alkali metal present is sodium.
- the sodium-Group IV B metal carbonate preferably acts as a bicarbonate provider or donor and therefore other materials capable of acting as a bicarbonate provider or donor can be also be used or alternatively can be used in the present invention.
- Other pH buffer materials that can be used as a bicarbonate provider in this invention include encapsulated sodium bicarbonate and ion exchange resins in carbonate form, and the like.
- the sodium-Group IV B metal carbonate is preferably a sodium zirconium carbonate.
- an alkali metal other than sodium can be used, such as potassium and the like (e.g., potassium- Group IV B metal carbonate, such as potassium zirconium carbonate). More preferably, the sodium zirconium carbonate has one or more of the following characteristics.
- the alkali metal-Group IV B metal carbonate e.g., sodium zirconium carbonate
- the sodium zirconium carbonate of the present invention preferably, in its final form, has from about 2 wt% to about 5 wt% Na + ; from about 44 wt% to about 50 wt% Zr0 2 ; from about 12 wt% to about 18 wt% C0 3 2' ; and from about 30 wt% to about 40 wt% LOD, based on the weight of the sodium zirconium carbonate, wherem LOD is the amount of weight lost on drying of the SZC.
- the sodium zirconium carbonate of the present invention preferably satisfies the standards set forth in ANSI/AAMI RD-5-1992 on extractable toxic impurities.
- the sodium zirconium carbonate of the present invention achieves one or more of the following properties or characteristics: a phosphate adsorption having a minimum capacity of from about 30 to about 35 mg P0 4 -P/gm SZC; other capacities can be used; - a minimum HC0 3 " content of from about 2 to about 4 mEq HC0 3 7gm SZC; other amounts can be present; a maximum leachable Na + content of from about 1.5 to about 2.0 mEq Na + /gm SZC; other amounts can be present; and/or a pH range of the titrated sodium zirconium carbonate of from about 6 to about 7. Other pHs can be used.
- the sodium zirconium carbonate of the present invention has at least one of the above characteristics and more preferably at least two or three, and even more preferably, all of the above characteristics.
- the sodium zirconium carbonate preferably provides the necessary potency requirements for peritoneal dialysis or hemodialysis applications by providing a sufficient phosphate adsorption capacity for economic use as a clinical sorbent for the treatment of, for instance, hyperphosphatemia of renal disease patients. Further, the sodium zirconium carbonate of the present invention preferably provides the specified bicarbonate content in a peritoneal dialysis or hemodialysis fluid during applications. The present invention further has the minimum leachable Na+ as described above.
- any amount of the alkali metal-Group IV B metal carbonate can be used in the sorbent cartridge, preferably amounts effective to remove substantially all if not all of the phosphate in the waste material of the blood is present. For instance, amounts ranging from about 50 grams to about 250 grams of the sodium-Group IV B metal carbonate is present based on from about 20 to about 140 mEqHC0 3 7L dialysate. More preferably, the amount of the alkali metal-Group IV B metal carbonate is from about 80 to about 120 grams.
- an ammonia adsorbent such as a zirconium phosphate, zeolite, titanium phosphate, zirconium silicate, organic ionic exchange resins, and the like.
- the ammonia adsorbent if used, is a zirconium phosphate (ZrP), and is preferably titrated zirconium phosphate.
- ZrP zirconium phosphate
- the zirconium phosphate is titrated ZrP in the Na + and/or H + form.
- a mixture of Na + and H " are present in the ZrP.
- the zirconium phosphate has one or more of the following characteristics: H + content of from about 1.4 to about 2.0 wt%;
- Other content amounts for the various characteristics can be used.
- the zirconium phosphate of the present invention preferably has an adsorption capacity for ammonia, Ca 2+ , Mg 2+ , K + , and toxic heavy metals. More preferably, the adsorption capacity is approximately from about 20 mg NH -N/gm ZrP to about 45 mg or more NH -N/gm ZrP, and more preferably at least about 30 mg NH -N/gm ZrP; from about 2 mEq Ca 2+ /gm ZrP to about 7 mEq Ca 2+ /gm ZrP, and more preferably at least about 3 mEq Ca 2+ /gm ZrP; from about 1 mEq Mg 2+ /gm ZrP to about 5 mEq Mg 2+ /gm ZrP, and more preferably at least about 2 mEq Mg + /gm ZrP; and from about 3 mEq HM/gm ZrP to about 9 mE
- the zirconium phosphate of the present invention preferably has a minimum leachable P0 3" for the material and more preferably is less than about 0.05 mg P0 4 3 7gm ZrP. Other amounts can be used.
- the zirconium phosphate preferably has an average grain size of from about 30 to about 40 microns and has no residual sulfate or chloride (e.g., less than
- the zirconium phosphate preferably satisfies the ANSI/AAMI RD-5-1992 standard on extractable toxic impurities and has a pH when in water of from about 6 to about 7. Further details of the preferred zirconium phosphate and methods of making them, for instance, are described in U.S. Patent Application No. 09/723,396, as mentioned above.
- the ammonia adsorbent preferably zirconium phosphate
- the amount of the ammonia adsorbent is a sufficient amount to remove at least partially if not substantially or entirely all of the ammonia present in the spent fluids.
- the amount of the ammonia adsorbent, and preferably zirconium phosphate, in a cartridge is from about 300 grams to about 750 grams and more preferably from about 500 to about 600 grams based generally on the dialysate mentioned above. This range is especially preferred for PD regeneration. Another range is preferably from about 800 grams to about 1900 grams in the cartridge and more preferably from about 1300 grams to about 1700 grams. These ranges are especially preferred by HD regeneration.
- overall ranges for the cartridge in general are from about 300 grams or less to about 1900 grams or more. Other amounts can be used.
- Another component which can be present in the cartridges of the present invention is zirconium oxide and preferably hydrous zirconium oxide and more preferably hydrous zirconium oxide (HZO) containing acetate (HZO-Ac).
- the hydrous zirconium oxide containing acetate preferably acts as a counter ion and serves as an ion exchanger to remove phosphate from uremic patients.
- the hydrous zirconium oxide can also prevent leaching of phosphate from NaHZrP and removes toxic anions present in water that may cause harm to a patient during dialysis.
- a weight ratio of hydrous zirconium oxide containing acetate and the sodium zirconium carbonate is an amount of from 50 grams/50 grams to about 200 grams/200 grams and more preferably 100 grams/100 grams wherein the ratio signifies HZO-Ac to SZC. Other amounts can be used as well.
- zirconium basic carbonate ZBC
- Group IV metal basic carbonates commercially available forms can be used as well as those described in any one of the patents and publications set forth below.
- a preferred Group IV metal carbonate is zirconium basic carbonate and more preferably has the following parameters: a zirconium basic carbonate having Na + content of less than about 1000 ppm; a Zr0 2 wt% of from about 35% to about 40%; and a C0 3 2" wt% of from about 8% to about 10%, based on the weight of the zirconium basic carbonate. Other amounts for each of these parameters can be used.
- sorbent cartridge materials that can also be present in the sorbent cartridge include, but are not limited to, alumina, alumina supported urease, granulated activated carbon, activated alumina, zeolites, diatomaceous earth, direct urea sorbents, and other conventional adsorbent(s), fillers, glass beads, and the like.
- alumina alumina supported urease
- granulated activated carbon activated alumina
- zeolites granulated activated carbon
- diatomaceous earth direct urea sorbents
- fillers glass beads, and the like.
- the sorbent cartridge contains at least an alkali metal-Group IV B metal carbonate such as sodium zirconium carbonate.
- alumina can be present in an amount of from about 100 grams or below to about 500 grams or above and more preferably from about 200 grams to about 350 grams and more preferably about 300 grams.
- a preferred particle size for the alumina is from about 20 microns or less to about 40 microns or more.
- the alumina is commercially available from sources like Alcoa.
- the immobilized urease preferably the immobilized urease is present in an amount of from about 100 grams to about 300 grams and more preferably from about 200 grams to about 250 grams.
- the activated carbon may be present in any amount and preferably is present in an amount of from about 100 grams or less to about 500 grams and more preferably from about 200 grams to about 300 grams and even more preferably at about 250 grams.
- the activated carbon is available from such sources as Calgon. These optional materials are commercially available and various types are also described in the patents and publications incorporated herein by reference.
- the particle sizes of the above materials are generally in the same ranges as for the SZC and/or ZrP, except for the activated carbon and immobilized enzyme. Preferred ranges are from 20 to about 120 microns for alumina; and from about 0.4 to about 1.2 mm (or 12-50 mesh sieve) for the activated carbon.
- Figures 4 through 6 provide exploded views of preferred materials in the adsorbent cartridges of the present invention as well as the preferred arrangement of the various layers contained in the adsorbent cartridges.
- the flow of the spent dialysate fluid enters from the bottom of the cartridge and exits at the top of the cartridge which is more clearly shown in Figure 8, for instance.
- Figure 4 provides a more preferred cartridge set up for the processing of spent dialysate from PD fluids
- Figures 5 and 6 provide a preferred set up for cartridges useful in the processing of spent dialysate from an HD system.
- Figure 5 is a more preferred set up for a cartridge useful for a 4 hour treatment
- Figure 6 is a preferred set up for an 8 hour treatment as described herein.
- these various layers can be substituted with other suitable materials or the layers can be rearranged.
- the layer containing the activated carbon or other suitable adsorbent can be located at the bottom of the cartridge and/or at the top of the cartridge.
- the various amounts of the various ingredients described throughout this application can be present in effective amounts to accomplish the various functions of each ingredient as set forth, for instance, in Figure 8. Any combination is possible.
- a sorbent cartridge is any container capable of being used for the separation or purification of a substance (which is preferably a liquid) and more preferably is used dialysate containing waste products and/or excess fluid.
- the sorbent cartridge generally has an inlet and an outlet and the cartridge can be any shape or size depending upon desired uses.
- Figure 1 provides one preferred design of a sorbent cartridge wherein the inlet and the outlet are identified as numeral 11 and numeral 13.
- Various shapes of the sorbent cartridge include, but are not limited to, a cylindrical shape, rectangular shape, a pyramidal-cylindrical shape as shown, for instance, in Figure 1 and so on. The shape can be straight-edged or tapered, and so on. Any geometric shape can generally be used.
- the PD cartridge has the following dimensions: 2 inches - 3 inches diameter by 5 inches to 10 inches length.
- the HD cartridge preferably has the following dimensions: 4 inches - 6 inches diameter by 6 inches - 12 inches long. Other dimensions can be used depending on the needs of the purifying, amount to purify, operating system and the like. Examples of cartridge designs are further shown in U.S. Patent Application No. , entitled “Filter Cartridge Assemblies and Methods of Filtering Fluids" filed November 28, 2001 naming Ralph P. Thompson as the inventor, and this application is incorporated in its entirety by reference herein. Examples of cartridges are also described in one or more of the patents and/or publications identified herein.
- the used dialysate passes through other layers first, if present, and then passes through the alkali metal-Group IV B metal carbonate or preferably the sodium zirconium carbonate layer.
- a preferred arrangement of layers is shown in Figure 4. If an immobilized enzyme layer is present, preferably, this layer is located before the zirconium phosphate layer or other suitable layer, if present. Again, in other words, the used dialysate passes first through the immobilized enzyme layer prior to passing through the layer containing the zirconium phosphate, if present.
- the sodium zirconium carbonate can be present any where in the cartridge, preferably the layer containing the sodium zirconium carbonate is located after the layer containing the zirconium phosphate, if present.
- a preferred order of layers is as follows, realizing that these layers and the materials in the layers are optional. a) sodium zirconium carbonate or other alkali metal-Group IV metal- carbonate b) zirconium phosphate or other ammonia adsorbent c) alumina or other like material d) alumina supported urease or other immobilized enzyme layer or other material to convert urea to ammonia such as diatomaceous earth or zirconium oxide e) granular activated carbon or other adsorbent.
- one or more filter pads can be located throughout the sorbent cartridge to ensure that the layer integrity is maintained during operation.
- the filter pad can be made of any type of material, for instance, standard filter paper or cellulose pads and the like and typically is the diameter or length-width of the cartridge in order to separate completely one layer from another layer.
- a filter pad is located above and in contact with the sodium zirconium carbonate layer.
- a second filter pad can be located between and in contact with the alumina supported urease layer and the granular activated carbon layer.
- a third filter pad can be located between and in contact with the granular activated carbon layer that faces the inlet of the sorbent cartridge.
- One or more of these filter pads can be used.
- a flow diffuser which uniformly diffuses the used dialysate throughout the entire width or diameter of the sorbent cartridge can preferably be used.
- the flow diffuser preferably has a design of radial spreading channels made of plastic or other suitable materials.
- the flow diffuser is, as shown in Figure 4, typically located prior to any of the optional filter pads or materials used in the sorbent cartridge and is adjacent to the inlet (or part of the inlet) of the sorbent cartridge.
- a barrier layer(s) can also be used in the sorbent cartridge.
- a barrier layer is preferably located between the immobilized enzyme layer and the alumina layer, if present.
- An example of a barrier layer includes filter paper and the like.
- the present invention relates to a particular order of materials present as layers in a sorbent cartridge as follows: adsorbent layer immobilized enzyme layer or other material to convert urea to ammonia optional barrier layer - optional alumina layer ammonia adsorbent phosphate adsorbent optional filter pad
- the ammonia adsorbent is a zirconium phosphate and the phosphate adsorbent is preferably a sodium zirconium carbonate.
- Immobilized urease or other enzyme layer for enzymatic conversion of urea to ammonium carbonate may be categorized as follows: a. Adsorption, e.g., alumina, activated carbon, anion-exchange resins, diatomaceous earth, or other conventional adsorbents that are commonly employed adsorbents. b. Covalent bond to water insoluble polymer to form enzyme-polymer conjugates via activation procedure or reactive polymer.
- the commonly employed water- insoluble supports for the covalent attachment of enzymes may include the following: Synthetic supports, e.g., - Acrylamide-based polymer
- Maleic anhydride-based polymers Polypeptides Styrene-based polymer Natural Supports, e.g., - Agarose (sepharose) - Dextran (sephadex)
- Cellulose Starch c. Intermolecular cross-linking of enzyme using multifunctional reagents e.g., ' glutaraldehyde, hexamethylene diamine. Cross-linking is usually after adsorption on porous support.
- d. Entrapment within cross-linked polymers, e.g., polyacrylamide gel.
- Microencapsulatio ⁇ e.g. nylon, cellulose nitrate, ethyl cellulose, polyamide.
- Containment within semi-permeable membrane devices e.g., Amicon ultra- filtration cells, Dow hollow fiber beaker device.
- Cation exchange materials in Na + or 1ft form as a NH -scavenger and adsorbent for infusate cations as well as toxic trace metals in tap water. Another function of the material is to convert carbonate from urea hydrolysis to bicarbonate.
- These may include cation exchange resins and inorganic ion exchange sorbents (cation type) such as zirconium phosphate, titanium phosphate, zeolite, and the like.
- Adsorbent for removal of creatinine, uric acid, and middle molecules of uremic toxins as well as organics in tap water Although activated carbon is the most effective sorbent for removing nitrogenous waste metabolites, other potential candidates may include certain ion-exchange resins and affinity chromatography materials such as derivatives of cellulose, polystrene gel, polyacrylamide gels, porous glass and agarose and the like.
- a component layer is preferred to remove the chlorine from tap water for dialysis or to use highly purified water.
- the material can be carbon- impregnated pads, granular activated charcoal, and the like.
- the component materials can be put in a mixed form or arranged in discrete layers separated by filter papers or cellulose pads, although the efficiency and performance are different. There can be various configurations for the layers.
- the chlorine removal layer if used, preferably precedes the urease-immobilized layer since chlorine can deactivate the enzyme.
- the NH 4 - scavenger or cation exchange layer preferably succeeds the urease-immobilized layer.
- the system set forth in Figure 2 can be used especially for hemodialysis; that is a single pass dialysis system or a system that is preferably used as a closed system as shown in Figure 3.
- the used dialysis can simply be collected in a container which then can be regenerated or purified by passing the spent dialysate through one or more cartridges as described above.
- the sorbent dialysis system shown in Figure 3 uses a cartridge as described above which is located as indicated in Figure 3. Such a system permits the continuous reusing of the regenerated dialysate in a patient during dialysis treatment.
- 15 identifies a source for electricity to operate the single pass dialysis system.
- 17 represents a flow meter
- 19 represents a conductivity meter
- 21 represents a temperature meter
- 23 represents a heater, all of which are conventional items used in single pass dialysis systems and are known to those skilled in the art and can be used in the system of the present invention.
- 25 represents a blood leak detector and 27 represents a UF meter which again are conventional items in a single pass dialysis system that are understood by those skilled in the art.
- 41 represents concentrate used to form the fresh dialysate
- 43 represents the water used to mix with the concentrate in order to form the fresh dialysate
- 45 represents the water treatment system used to purify the water prior to the mixing of the water with the concentrate. Again, these items are conventional in dialysis systems and commercially available items can be used in the present invention.
- 47 represents a container or drain to collect the used dialysate in order to be purified or regenerated by the cartridges of the present invention.
- 67 represents a dialyzer which is the same as in Figure 2.
- 69 represents used dialysis leaving the dialyzer and 71 represents fresh dialysate entering the dialyzer 67.
- 73 is a pump to pump the used dialysate from the dialyzer into the cartridge 75 which are the cartridges of the present application.
- the cartridges of the present invention are made for 4 hours of dialysis treatment or for 8 hours of dialysis treatment.
- the 8 hour cartridges are typically made for home use and the 4 hour cartridges are typically made for dialysis treatment in medical treatment or dialysis centers.
- the cartridges of the present invention can generally be used with any type of dialysis system as described above.
- the flows that pass through the cartridge are typically any conventional flows. For instance, flows from about 50 ml/min or less to 500 ml/min or more of dialysate can flow through the cartridge and can be used in the systems of the present invention. Other flows can be used depending upon the size of the cartridge and the operating system.
- the cartridges of the present invention have the ability to maintain and/or restore in dialysate the Na + and/or HC0 " amounts that should be present in fresh dialysate as well as in a patient's blood that is being treated by way of the dialysis system of the present invention.
- the present invention provides useful embodiments that allow the
- the dialysate regeneration system was set up as shown in Figure 7. As shown in
- a test system can be arranged wherein there are various locations where the sampling of the dialysate fluid can occur as well as sampling of the simulated patient fluid which can be the simulation of the waste products found in blood or a PD fluid.
- Sampling No. 1 provides the ability to sample the content of the spent dialysate fluid or PD fluid prior to its entry into the cartridge.
- Sampling No. 2 permits the testing of the dialysate or PD fluid once it has been regenerated by the cartridge of the present invention.
- Sampling No. 3 permits the sampling of the regenerated dialysate fluid or PD fluid after the fluid has been infused with the standard components of an infusate which typically introduces calcium and magnesium ions so as to restore them to acceptable levels.
- the patient was represented by a simulated fluid bath of 60 liters volume of the following composition at 37°C.
- the simulated patient was dialyzed by using a Baxter PSN-120 dialyzer at the blood flow rate (BFR) of 180 ml/min.
- BFR blood flow rate
- the 6L dialysate was made up in tap water with a starting concentration as follows:
- the spent dialysate was regenerated by a sorbent cartridge of the following configuration at the dialysate flow rate (DFR) of 250 ml/min.
- Infusate was provided at a calibrated flow rate to maintain Ca 2+ , Mg 2+ , and K + balance in the regenerated dialysate.
- the efficacy and performance of the treatment are demonstrated by the following results:
- GAIN (Post-dialysis Na + Level - Pre-dialysis Na + Level) x patient dialyzable fluid volume V
- the two-loop PD regenerative system using a dialyzer was set up according to Figure 7.
- the spent PD fluid was represented by a simulation bath of the following composition:
- the dialysate was re-circulated through a sorbent cartridge for purification at the flow rate of 100 ml/min, and provided continuously with infusate after regeneration to replace the Ca 2+ and Mg 2+ removed by the cartridge, so that the Ca + and Mg 2+ levels in the PD fluid can be maintained and controlled.
- the sorbent cartridge used to purify the PD dialysate has the following configuration:
- the cartridge served to continuously remove the uremic toxins (urea, creatinine, and phosphate) that were dialyzed across the dialyzer from the spent PD fluid into the dialysate. At the same time, it served to remove the Ca 2+ and Mg 2+ from the dialysate so that with the help of infusate provisions, the balance of these ions in the PD fluid was maintained.
- uremic toxins urea, creatinine, and phosphate
- Adsorption efficiency No leakage of uremic toxic and Ca 2+ , Mg 2+ , were observed from the cartridge.
Abstract
Description
Claims
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
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AU2002217930A AU2002217930B2 (en) | 2000-11-28 | 2001-11-28 | Cartridges useful in cleaning dialysis solutions |
JP2002545825A JP3956363B2 (en) | 2000-11-28 | 2001-11-28 | Cartridge useful for washing dialysate |
AU1793002A AU1793002A (en) | 2000-11-28 | 2001-11-28 | Cartridges useful in cleaning dialysis solutions |
CA002427985A CA2427985C (en) | 2000-11-28 | 2001-11-28 | Cartridges useful in cleaning dialysis solutions |
EP01998401.2A EP1345687B1 (en) | 2000-11-28 | 2001-11-28 | Cartridges useful in cleaning dialysis solutions |
MXPA03004689A MXPA03004689A (en) | 2000-11-28 | 2001-11-28 | Cartridges useful in cleaning dialysis solutions. |
HK04102018.0A HK1059061A1 (en) | 2000-11-28 | 2004-03-18 | Cartridges useful in cleaning dialysis solutions |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US09/723,396 US6627164B1 (en) | 2000-11-28 | 2000-11-28 | Sodium zirconium carbonate and zirconium basic carbonate and methods of making the same |
US09/723,396 | 2000-11-28 |
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WO2002043859A2 true WO2002043859A2 (en) | 2002-06-06 |
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PCT/US2001/044660 WO2002043859A2 (en) | 2000-11-28 | 2001-11-28 | Cartridges useful in cleaning dialysis solutions |
PCT/US2001/044623 WO2002044086A2 (en) | 2000-11-28 | 2001-11-28 | Sodium zirconium carbonate and zirconium basic carbonate and methods of making the same |
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EP (2) | EP1345687B1 (en) |
JP (4) | JP4159355B2 (en) |
CN (5) | CN100569658C (en) |
AU (3) | AU2002217926A1 (en) |
CA (4) | CA2427992C (en) |
HK (2) | HK1058782A1 (en) |
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