EP0647130A1 - Procede et liquides d'hemodialyse comprenant de l'acide chlorhydrique - Google Patents

Procede et liquides d'hemodialyse comprenant de l'acide chlorhydrique

Info

Publication number
EP0647130A1
EP0647130A1 EP93911157A EP93911157A EP0647130A1 EP 0647130 A1 EP0647130 A1 EP 0647130A1 EP 93911157 A EP93911157 A EP 93911157A EP 93911157 A EP93911157 A EP 93911157A EP 0647130 A1 EP0647130 A1 EP 0647130A1
Authority
EP
European Patent Office
Prior art keywords
acid
concentrate
fluid
alkalizer
buffer
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.)
Withdrawn
Application number
EP93911157A
Other languages
German (de)
English (en)
Inventor
Louis C. Cosentino
Walter B. Jansen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Minntech Corp
Original Assignee
Minntech Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Minntech Corp filed Critical Minntech Corp
Publication of EP0647130A1 publication Critical patent/EP0647130A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61M1/1654—Dialysates therefor

Definitions

  • the invention relates to the composition of an aqueous dialysate fluid used in the machine hemodialysis of human blood, most commonly, in the treatment of patients having end-stage renal failure. More particularly, the invention resides in a dialysate fluid system that can be used in available hemodialysis units at typical blending ratios or reagent proportions.
  • the dialysate system can be used without the drawbacks of anions in the dialysate that can cause fatigue (weakness), nausea, vomiting and other debilitating symptoms.
  • Hemodialysis is a process in which solute molecules, which constitute undesirable waste products in human blood, can be transported (i.e., removed from the blood stream) across a membrane into a dialysis fluid.
  • the driving force of such transport is (1) the difference in pressure across the membrane and (2) the difference in chemical potential of each individual solute molecule across the membrane.
  • Dialysis requires that membranes separating blood from d lysis fluid permit diffusional transfer of at least ⁇ date.me of the molecular species present in blood into the fluid while effectively preventing any return contamination of blood or commingling of the blood and the dialysis fluid.
  • Dialysis is a passive separation process with low operating costs using no external thermal or chemical energy sources.
  • the basic hemodialysis separation obtained is between large cells and molecules, such as RBC, BC and proteins, and small molecules such as urea, electrolytes, and other small molecule metabolites.
  • machines are designed with large areas of membranes and are used at relatively small flow rates.
  • Modern hemodialysis machines utilize small diameter hollow-fiber dialysis membranes bathed in dialysate fluids.
  • Such membranes are in the form of a cylindrical cartridge having a large number of hollow-fiber membranes in fluid connection with a blood inlet and outlet.
  • the blood flows through the hollow interior membrane space.
  • the hollow-fiber membrane exterior is bathed in dialysate fluid.
  • Hollow-fiber membranes are typically manufactured from cellulose derivatives such as cellulose ester and other polymeric materials such as, polysulfone, polyacrylonitrile, polymethylmethacrylate, polyamide, polyimidazole, hollow-fiber glass, etc.
  • Dialysis fluids are prepared with a pH and composition compatible with blood.
  • a buffer is added to adjust the pH of the fluid to an acceptable value for blood compatibility.
  • This buffer may be sodium acetate, sodium bicarbonate, or other similar material capable of adjusting the pH and maintaining blood compatability.
  • Use of sodium acetate has been linked to patient symptoms of hypotension and fatigue, as well as other debilitating physical effects.
  • the use of bicarbonate in dialysis minimizes the formation of sodium acetate during pH adjustment. Accordingly, a need exists for development of an acetate-free dialysis fluid for use in hemodialysis.
  • dialysate fluids of the invention are typically prepared in a three-stream dilution by combining an alkalizer/buffer concentrate stream and an acid concentrate stream with a stream comprising an aqueous, non- pyrogenic, stable, bacteria-free diluent.
  • Such a three-stream system when operated at appropriate ratios of alkalizer/buffer to diluent and acid to alkalizer/buffer, produces the useful dialysate composition of the invention.
  • Figure 1 is a block diagram of typical hemodialysis equipment containing machine elements for the preparation of the dialysate fluid and elements to direct fluid to the membrane within the artificial kidney to remove contaminants from patient's blood.
  • an alkalizer/buffer concentrate and an acid concentrate are added to an aqueous diluent stream at appropriate mixing ratios to produce the useful dialysate fluid which is directed to the dialysis membrane.
  • the acid concentrate has a pH less than about 3.0, while the alkalizer/buffer has a pH greater than about 7.4.
  • the alkalinity of the alkalizer/buffer and the acid of the acid concentrate neutralize to a pH of 6.8-7.4.
  • the source of bicarbonate ion typically comprises alkali metal bicarbonate salts.
  • Such materials in aqueous solution typically yield bicarbonate ion and, depending upon pH, some free carbonate (CO 3 - 2 ) ion.
  • the relative proportions of carbonate and bicarbonate ions typically depend on the pH of the alkalizer/buffer solution and the amount of bicarbonate salt initially added to form the alkalizer/buffer solution.
  • the alkalizer/ buffer solution must contain, at a minimum, a source of bicarbonate (HCO 3 -) ion.
  • the alkalizer/buffer material can contain other ionized and non- ionized solutes that are compatible in aqueour -solution w; n the dialysis product and the source of carbonate and bicarbonate ion.
  • the alkalizer/buffer concentrate consists essentially of a source of bicarbonate as a source of alkalinity.
  • the alkalizer/buffer solution contains little or no other materials that significantly contribute to the alkaline pH of the alkalizer/buffer material.
  • the amount of bicarbonate in the concentrate depends primarily on the blending ratio of concentrate to diluent stream used in the production of a pH of 6.8 to 7.4 in the hemodialysis dialysate fluid. Each type of hemodialysis machine has a characteristic dilution ratio.
  • the concentrates are formulated for the dilution ratio of the machine.
  • the acid concentrate material used in preparing the dialysate fluid is typically prepared in aqueous solution with HCl in combination with other solutes.
  • the amount of acid used in the acid concentrate also depends on the hemodialysis machine used and the blending ratio characteristic of the machine.
  • the acid concentrate material of the invention can contain a physiologically compatible acid in sufficient amount to result in a minimum of at least 1 millimolar acid for the dialysate fluid in a 45X machine or a 36.83X machine, or higher, depending on the operating concentration selected.
  • physiologically campatible acid we mean acid that, in the concentrations used in the dialysate fluid, produces little or no adverse physiological impact on the blood present in the hemodialysis machine or on the patient undergoing dialysis.
  • physiologically compatible acid we mean an acid having an acid cation which is identical to or significantly related to cations present in normal human metabolism.
  • the concentration of acid in the concentrates diluted to form the dialysate fluids.of the invention can be increased to increase resistance to precipitate, typically carbonate fractions in the dialysis fluid during use.
  • the concentrates can be used to provide HCl at a concentration sufficiently high to result in adding at least one millimole, into the final dialysis fluid concentration which can effectively prevent the production of harmful precipitates at a dialysate fluid pH between 6.8 and 7.4, preferably 6.8 . _. 7.2.
  • the dialysate fluid of the inve ion c ⁇ .n also contain a variety of other physiological solutes and other solutes useful in treating the dialysis patient.
  • Solutes common in humans include sodium, potassium, chloride, calcium, magnesium, phosphate, dextrose, sulfate, iron, copper, and others.
  • the amount of such materials in the dialysate fluid is adjusted for the requirements of the individual dialysis patient. For example, the amount of dextrose used must be tailored for the diabetic patient.
  • the amounts of Ca++, Na+, and K+ must be tailored for the cardiac patient.
  • the .alysate fluids can contain, in each liter, from about 75 t 150 milliequivalents of sodium ion, 0 to 4 milliequivalents of potassium ion, 0 to 4 milliequi-"-alents of calcium ion, 0 to 1.5 milliequivale-.ts of magnesiui.. ion, 70 to 115 milliequivalents of chloride ion, 20 to 40 milliequivalents of bicarbonate ion, etc.
  • the fluid can also contain 0 to 250 milligrams of dextrose per 100 ml of dialysate fluid. Other solutes present in the dialysate solution can be tailored to the specific patient.
  • the dialysate solution can contain hormones, antibiotics, anticoagulants, and other nutrients.
  • Useful hormones include materials such as insulin, steroids, prostaglandins, etc.; antibiotics include penicillin, cephlo-sporins, etc.; anticoagulants such as heparin, coumarin anticoagulants, indan- 1,3-dione coagulants; and nutrients such as amino acids, dextrose, vitamins, etc.
  • Machines used in hemodialysis contain sensors, pumps, and control units that control the flow rate, flow direction, fluid pressure, fluid temperature, dilution ratios of the buffer alkalizer concentrate and the acid concentrate into the diluent water stream.
  • FIG. 1 shows a block diagram of a typical dialysis machine.
  • the artificial kidney or membrane cartridge 11 is shown having an inlet 11a and an outlet lib to permit the flow of blood through the cartridge.
  • Blood comes from the patient 13 through a blood pump 12 through the cartridge 11 and returns to the patient 14.
  • the dialysate fluid is blended in a proportioning pump 18 by combining treated diluent water 15, acid concentrate 16, and bicarbonate (alkalizer/buffer) concentrate 17. These materials are blended at a machine set dilution rate (36.83X or 45X) to produce a final dialysate stream 19.
  • the dialysate stream 19 passes through a heater/mixer 20 which ensures uniformity and physiological temperature.
  • the proper operation of the dialysis machine is monitored by a conductivity monitor 21, thermometer 22, and pressure regulator 23.
  • the dialysate fluid stream 19 passes into the cartridge 11 through inlet lie, wherein the fluid contacts the exterior of the hollow dialysis membrane containing the blood in the internal membrane passage.
  • the dialysate receives material by diffusion from the blood across the membrane.
  • the contaminated dialysate 25 leaves the cartridge at outlet lid due to the influence of pump 26 and is directed to a drain.
  • the alkalizer/buffer material is blended within a three-stream dilution unit at a ratio of 1.6 to 2 parts by volume of the alkalizer/buffer concentrate per each part by volume of the acid concentrate.
  • alkalizer/buffer material is used with each part by volume of the acid concentrate material in the three-stream hemodialysis equipment dilution system.
  • about 30 to 50 parts of purified water pyrogen- free, bacteria-free, USP or equivalent
  • purified water pyrogen- free, bacteria-free, USP or equivalent
  • 45X hemodialysis systems for each part of the acid concentrate, 1.72 parts of the alkalizer/buffer about 42.28 parts (vol.) of purified water is used.
  • 36.83X systems for each part of acid concentrate, 1.83 parts alakalizer/buffer in 35 parts (vol.) of purified water are used.
  • the dialysate fluid is blended by combining the three streams in a blending unit and is directly introduced into the housing or cartridge holding the membrane (artificial kidney) . .
  • the fluid obtains the impurities from the blood held in the interior of the membrane by diffusion through the membrane's surface to the exterior dialysate fluid.
  • the contaminated fluid is directed out of the housing to a drain.
  • the blending equipment of the hemodialysis unit is operated at a rate such that about 250 to 1000 ml of dialysate fluid are delivered to the exterior surface of the membrane (artificial kidney) unit per minute having the constituents proportioned as described above.
  • the preferred rate of dilution of the concentrates and purified water results in a stream of about 400 to 600 ml of dialysate fluid per minute.
  • Proper proportioning of the dialysate constituents during dilution and subsequent hemodialysis can readily be monitored by a conductivity sensor because the relative conductivities of the aqueous diluent (low conductivity) and the concentrates (high conductivity) are significantly different from the conductivity of the diluted fluid. Should the dilution system fail and deliver diluent or concentrate to the dialysis unit, conductivity sensors can monitor and terminate flow at that time. The conductivity of the fluid should preferably be maintained at about 13.0 to 14.5 milliSiemens.
  • dialysate fluids are prepared from an acid concentrate and an alkalizer/buffer.
  • the preferred alkalizer/buffer material used in the invention contains about 50 to 95 grams of sodium bicarbonate per liter of material or can contain about 10 to 30 grams of sodium chloride and 40 to 90 grams sodium bicarbonate. Perferably, the alkalizer/buffer material contains about 80 to 85 grams of sodium bicarbonate per liter.
  • Typical aqueous acid concentrates suitable for combination with the alkalizer/buffer material set forth above are prepared as illustrated hereafter:

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Emergency Medicine (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

Du sang provient d'un patient (13) par une pompe à sang (12), par un rein artificiel ou une cartouche à membrane (11) et revient vers le patient (14). Le fluide de dialysat est mélangé dans une pompe de dosage (18) par combinaison de l'eau diluante traitée (15), d'un concentré d'acide (16) et d'un concentré de bicarbonate (alcalinisant/tampon) (17). Ces matières sont mélangées à une vitesse de dilution (36,83X ou 45X) réglée par la machine, de façon à produire un courant de dialysat final (19). Le fluide de dialysat final possède au moins 1 millimole d'acide ajouté. Le courant de fluide de dialysat (19) pénètre dans la cartouche (11) où il vient en contact avec l'extérieur de la membrane de dialyse creuse contenant le sang. Le dialysat contaminé (25) sort de la cartouche en passant par la pompe (26) et est dirigé vers un conduit d'évacuation.
EP93911157A 1992-06-03 1993-05-06 Procede et liquides d'hemodialyse comprenant de l'acide chlorhydrique Withdrawn EP0647130A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US89256492A 1992-06-03 1992-06-03
US892564 1992-06-03
PCT/US1993/004351 WO1993024108A1 (fr) 1992-06-03 1993-05-06 Procede et liquides d'hemodialyse comprenant de l'acide chlorhydrique

Publications (1)

Publication Number Publication Date
EP0647130A1 true EP0647130A1 (fr) 1995-04-12

Family

ID=25400143

Family Applications (1)

Application Number Title Priority Date Filing Date
EP93911157A Withdrawn EP0647130A1 (fr) 1992-06-03 1993-05-06 Procede et liquides d'hemodialyse comprenant de l'acide chlorhydrique

Country Status (6)

Country Link
EP (1) EP0647130A1 (fr)
JP (1) JPH07504591A (fr)
AU (1) AU4239593A (fr)
CA (1) CA2137088A1 (fr)
HU (1) HUT68062A (fr)
WO (1) WO1993024108A1 (fr)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EG24303A (en) * 1998-10-20 2009-01-12 Advanced Renal Technologies Buffered compositions for dialysis
US7670491B2 (en) 1998-10-20 2010-03-02 Advanced Renal Technologies Buffered compositions for dialysis
US8105258B2 (en) 1999-04-26 2012-01-31 Baxter International Inc. Citrate anticoagulation system for extracorporeal blood treatments
US7186420B2 (en) 1999-04-26 2007-03-06 Edwards Lifesciences Corporation Multi-part substitution infusion fluids and matching anticoagulants
AU4553700A (en) 1999-04-26 2000-11-10 Pe Chou Chang Substitution infusion fluid and citrate anticoagulation
DE19955578C1 (de) 1999-11-18 2001-09-06 Fresenius Medical Care De Gmbh Mehrkammerbehälter, mit Glucosekonzentratkompartiment und Salzsäurekonzentratkompartiment
US7445801B2 (en) 2002-06-07 2008-11-04 Baxter International Inc. Stable bicarbonate-based solution in a single container
CN100457203C (zh) * 2006-01-10 2009-02-04 赵滨宇 血液透析循环装置

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4399036A (en) * 1979-06-14 1983-08-16 Diachem, Inc. Proportioning system for bicarbonate dialysate
US4366881A (en) * 1980-12-11 1983-01-04 J. I. Case Company Flip-up control console

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9324108A1 *

Also Published As

Publication number Publication date
JPH07504591A (ja) 1995-05-25
HUT68062A (en) 1995-05-29
HU9403380D0 (en) 1995-02-28
WO1993024108A1 (fr) 1993-12-09
CA2137088A1 (fr) 1993-12-09
AU4239593A (en) 1993-12-30

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