WO1986003407A1 - Bacteriostatic hemodialysis concentrate - Google Patents

Bacteriostatic hemodialysis concentrate Download PDF

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Publication number
WO1986003407A1
WO1986003407A1 PCT/US1985/002375 US8502375W WO8603407A1 WO 1986003407 A1 WO1986003407 A1 WO 1986003407A1 US 8502375 W US8502375 W US 8502375W WO 8603407 A1 WO8603407 A1 WO 8603407A1
Authority
WO
WIPO (PCT)
Prior art keywords
bicarbonate
concentrate
sodium
sodium chloride
per liter
Prior art date
Application number
PCT/US1985/002375
Other languages
French (fr)
Inventor
Louis C. Cosentino
Anatol M. Hnojewyj
Walter B. Jansen
Original Assignee
Renal Systems, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Renal Systems, Inc. filed Critical Renal Systems, Inc.
Publication of WO1986003407A1 publication Critical patent/WO1986003407A1/en
Priority to NO1986863089A priority Critical patent/NO863089D0/en
Priority to FI863187A priority patent/FI863187A0/en
Priority to DK375586A priority patent/DK375586A/en

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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
    • 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
    • A61M1/1656—Apparatus for preparing dialysates
    • A61M1/1666—Apparatus for preparing dialysates by dissolving solids

Definitions

  • This invention is directed to hemodialysis solu- tions and more particularly to dialysis concentrate.
  • Dialysis fluids for hemodialysis must contain either acetate, bicarbonate or other similar buffers to maintain the pH of the solution within acceptable limits. Most hemodialysis solutions contain either sodium acetate or sodium bicarbonate buffer.
  • Bicarbonate hemodialysis is preferred over ace ⁇ tate hemodialysis. Less dialysis induced morbidity and vascular instability has been reported when bicarbonate is used instead of acetate; When acetate is metabolized by the body undesirable triglyceride levels may be formed.
  • dialyzing solutions are prepared by use of commercial liquid concentrate. When appropriately diluted, the desired electrolyte concentration is obtained.
  • Sodium acetate has been traditionally used rather than bicarbonate to maintain stability in storage.
  • Acetate concentrate was usually considered to be • bactericidal.
  • bicarbonates are less desirable than acetate is the lack of ionic stability and the growth of microorganisms within the bicarbonate concentrate.
  • sodium bicarbonate concentrate includes sodium chloride.
  • the level of sodium chloride in the concentrate has always been less than about 23.8 grams per liter. Such solutions are not adequately bactericidal or bacteriostatic.
  • compositions which, when properly diluted, yield bicarbonate hemodiaysis solu- tion.
  • inventive compositions provide acid hemodialysis concentrate and bicarbonate concentrate which are bac ⁇ teriostatic and bactericidal in the same manner as acetate concentrate.
  • Hemodialysis solution is typically prepared by mixing together and diluting an acid concentrate and a bicarbonate concentrate.
  • the typical acid concentrate includes sodium chloride, calcium chloride, potassium chloride, magnesium chloride, acetic acid and dextrose.
  • the sodium chloride level in the acid concentrate was typi- cally at a concentration which resulted in a pH of between 0.8 and 3.0 which is bacteriostatic.
  • bicarbonate concentrate was prepared with sodium bicar ⁇ bonate and sodium chloride concentration below 23.8 grams per liter. Such prior art bicarbonate concentrates are not bacteriostatic or bactericidal.
  • the inventor has discovered that a bactericidal and bacteriostatic bicarbonate concentrate is formed when ⁇ ever the sodium chloride concentration exceeds approximate ⁇ ly about 28 grams per liter.
  • the inventor reduced the quantity of sodium chloride in the acid con ⁇ centrate such that the total amount of sodium chloride pre ⁇ sent in the final hemodialysis solution would be unchanged.
  • the inventor found that when the bicarbonate concentrate is made bactericidal by increasing the sodium chloride concentration, the corresponding decrease of sodium chloride in the acid concentrate did not make the acid concentrate non-bacteriostatic. It was found that the pH of acid concentrate having a lower sodium chloride con- tent was between 0.8 and 3.0 which provides bacteriostatic properties.
  • Hemodialysis solutions may be formulated on site with the use of three stream artificial kidney machines such as the AK-10 system as sold by Gambro, Inc.
  • the ad ⁇ vantages of the invention may be realized by shipping powdered chemical compositions which are pre-measured such that the addition of a specified quantity of water will result in the bateriostatic and bactericidal concentrates.
  • the powdered chemcials m,ay be diluted with water through the use of a RenapakTM processing machine as sold by Renal Systems, Inc of Minneapolis, Minnesota.
  • the acid concentrate may be prediluted with water to its bac ⁇ teriostatic concentration. Either the powdered bicarbonate concentrate composition or the diluted bicarbonate con ⁇ centrate composition may then be utilized.
  • compositions will be bactericidal and bac ⁇ teriostatic.
  • Powdered formulations are of course bac- teriostatic to begin with and when properly diluted provide the bacteriostatic concentrate properties of the invention.
  • Bicarbonate containing hemodialysis solution usually includes sodium chloride, calcium chloride, potassium chloride, magnesium chloride, acetic acid, sodium bicarbonate and, optionally, dextrose.
  • the exact quantity of each ion within a hemodialysis solution may vary depending on the needs of a particular patient.
  • typical hemodialysis solution has about 140 milliequivalents per liter of sodium, 3.5 milliequivalants per liter of calcium, 1 milliequivalent per liter of magne ⁇ sium, 1 milliequivalants per liter of potassium, 106.5 milliequivalents per liter of chloride, 35 milliequivalents per liter of bicarbonate and 4 milliequivalents per liter of sodium acetate.
  • the concentration of each may be vary up or down in custom prepared solutions. Most manufac ⁇ turers supply a series of hemodialysis solutions which have varying concentrations of the chemical species there- within.
  • the advantages of the invention may be achieved such that any of the commercially available, standard hemo ⁇ dialysis solutions or custom hemodialysis solutions may be produce .
  • the invention involves providing sufficient sodium chloride in a bicarbonate concentrate such that the concentration of sodium chloride in the bicar ⁇ bonate concentration is at least 28 grams per liter. The higher the concentration of sodium chloride in the bicar- bonate concentrate, the lower the sodium chloride con ⁇ centration is in the acid concentrate. The total amount of sodium chloride in hemodialysis solution prepared from the bactericidal and bacteriostatic bicarbonate and acid con ⁇ centrates remains unchanged. As the quantity of sodium chloride within the bicarbonate concentrate increases it decreases in the acid concentrate, such that the total amount of sodium chloride in the final hemodialysis solu ⁇ tion is unchanged.
  • the concentration of NaCl is grams per liter in the bicarbonate concentrate is about 35.3 or higher.
  • the higher concentrations of salt have even greater bacteriostatic properties.
  • the concentration of NaCl is limited by its solubility characteristics when in solution with sodium bicarbonate. At temperature ranges in which the concentrate will probably be used in forming dialysis solution the maximum concentration of NaCl would be about 200 grams/liter.
  • the normal concentration of bicarbonate in a human body is about 20 milliequivalents (meq.) per liter. Hemodialysis usually involves a solution having about 39 meq. bicarbonate per liter. However, in some applications, the dialysis may involve 20 to as low as 15 meq. bicar ⁇ bonate per liter.
  • the maximum sodium bicarbonate in the bicarbonate concentrate would be about 164 grams/liter if the concentrate is prepared at an elevated temperature.
  • the concentration of sodium chloride in the acid concentrate depends on the concentration of sodium chloride in the bicarbonate concentrate. The maximum sodium chloride concentration in the acid concentrate is limited by the necessity of maintaining at least 28 grams per liter of sodium chloride in the bicarbonate concentrate. The concentration of sodium chloride in the acid concentrate may be zero, with all of the sodium chloride being present in the bicarbonate concentrate.
  • bicarbonate concentrate In order to make up 36.83 liters of prepared hemodialysis solution, acid concentrate and bicarbonate concentrate were prepared to the above concentrations.
  • the bicarbonate concentrate consisted of 96.8 grams NaCl and 120.6 grams of sodium bicarbonate diluted to 1.83 liters with water.
  • the acid concentrate was prepared by adding 118.4 grams NaCl, 9.5 grams calcium chloride, 5.5 grams potassium chloride, 3.7 grams magnesium chloride, 8.8 grams acetic acid and 73.7 grams dextrose to water to a total of 1.0 liter. Both the acid concentrate and bicarbonate con ⁇ centrate prepared as detailed above are bacteriostatic.
  • Dialysis solution is prepared by adding 34.83 liters of water, 1.83 liters of bicarbonate concentrate and 1.0 liters of acid concentrate together.
  • the bicarbonate and/or acid concentrates may be prepared from the raw powder constitutes singly or more preferably from prepackaged containers which, when diluted as indicated on the label, will yield the bacteriostatic concentrates of the invention.

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  • Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Emergency Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • External Artificial Organs (AREA)
  • Food Preservation Except Freezing, Refrigeration, And Drying (AREA)

Abstract

Hemodialysis bicarbonate and acid concentrates which are bacteriostatic and bactericidal. Sodium bicarbonate concentrate is made biocidal by including greater than 28 grams per liter of sodium chloride. The excess sodium chloride in the bicarbonate concentrate is obtained from a decrease in the sodium chloride concentration in the acid concentrate. Powdered mixtures having the proper ratios of sodium chloride to bicarbonate may be dissolved in purified water used in hemodialysis to obtain the biocidal hemodialysis concentrates.

Description

BACTERIOSTATIC HEMODIALYSIS CONCENTRATE - - DESCRIPTION
Field of the Invention This invention is directed to hemodialysis solu- tions and more particularly to dialysis concentrate.
Background of the Invention Dialysis fluids for hemodialysis must contain either acetate, bicarbonate or other similar buffers to maintain the pH of the solution within acceptable limits. Most hemodialysis solutions contain either sodium acetate or sodium bicarbonate buffer.
Bicarbonate hemodialysis is preferred over ace¬ tate hemodialysis. Less dialysis induced morbidity and vascular instability has been reported when bicarbonate is used instead of acetate; When acetate is metabolized by the body undesirable triglyceride levels may be formed.
Most dialyzing solutions are prepared by use of commercial liquid concentrate. When appropriately diluted, the desired electrolyte concentration is obtained. Sodium acetate has been traditionally used rather than bicarbonate to maintain stability in storage. Acetate concentrate was usually considered to be•bactericidal.
The major reason bicarbonates are less desirable than acetate is the lack of ionic stability and the growth of microorganisms within the bicarbonate concentrate. Traditionally, sodium bicarbonate concentrate includes sodium chloride. However, the level of sodium chloride in the concentrate has always been less than about 23.8 grams per liter. Such solutions are not adequately bactericidal or bacteriostatic.
Summary of the Invention The present invention provides compositions which, when properly diluted, yield bicarbonate hemodiaysis solu- tion. The inventive compositions provide acid hemodialysis concentrate and bicarbonate concentrate which are bac¬ teriostatic and bactericidal in the same manner as acetate concentrate.
Hemodialysis solution is typically prepared by mixing together and diluting an acid concentrate and a bicarbonate concentrate. The typical acid concentrate includes sodium chloride, calcium chloride, potassium chloride, magnesium chloride, acetic acid and dextrose. The sodium chloride level in the acid concentrate was typi- cally at a concentration which resulted in a pH of between 0.8 and 3.0 which is bacteriostatic. As stated above, bicarbonate concentrate was prepared with sodium bicar¬ bonate and sodium chloride concentration below 23.8 grams per liter. Such prior art bicarbonate concentrates are not bacteriostatic or bactericidal.
The inventor has discovered that a bactericidal and bacteriostatic bicarbonate concentrate is formed when¬ ever the sodium chloride concentration exceeds approximate¬ ly about 28 grams per liter. In order to add additional sodium chloride to a bicarbonate concentrate, the inventor reduced the quantity of sodium chloride in the acid con¬ centrate such that the total amount of sodium chloride pre¬ sent in the final hemodialysis solution would be unchanged. Surprisingly, the inventor found that when the bicarbonate concentrate is made bactericidal by increasing the sodium chloride concentration, the corresponding decrease of sodium chloride in the acid concentrate did not make the acid concentrate non-bacteriostatic. It was found that the pH of acid concentrate having a lower sodium chloride con- tent was between 0.8 and 3.0 which provides bacteriostatic properties.
Bacteriostatic and bactericidal qualities of the acid concentrate and bicarbonate concentrate solutions are achieved with the use of materials which are already in routine application in dialysis therapy. Long term studies to show compatibility for human use is not required since the final hemodialysis solution will have the same parame¬ ters as was previously provided by the prior art mixtures. The distinct advantages in using bicarbonate may be achieved without the undesirable microorganism growth which had previously been encountered with the use of bicarbonate concentrate.
Hemodialysis solutions may be formulated on site with the use of three stream artificial kidney machines such as the AK-10 system as sold by Gambro, Inc. The ad¬ vantages of the invention may be realized by shipping powdered chemical compositions which are pre-measured such that the addition of a specified quantity of water will result in the bateriostatic and bactericidal concentrates. The powdered chemcials m,ay be diluted with water through the use of a Renapak™ processing machine as sold by Renal Systems, Inc of Minneapolis, Minnesota. Alternatively, the acid concentrate may be prediluted with water to its bac¬ teriostatic concentration. Either the powdered bicarbonate concentrate composition or the diluted bicarbonate con¬ centrate composition may then be utilized. In any of the forms which the hemodialysis solution user receives the composition, the compositions will be bactericidal and bac¬ teriostatic. Powdered formulations are of course bac- teriostatic to begin with and when properly diluted provide the bacteriostatic concentrate properties of the invention.
Detailed Description of the Invention Bicarbonate containing hemodialysis solution usually includes sodium chloride, calcium chloride, potassium chloride, magnesium chloride, acetic acid, sodium bicarbonate and, optionally, dextrose. The exact quantity of each ion within a hemodialysis solution may vary depending on the needs of a particular patient. However, typical hemodialysis solution has about 140 milliequivalents per liter of sodium, 3.5 milliequivalants per liter of calcium, 1 milliequivalent per liter of magne¬ sium, 1 milliequivalants per liter of potassium, 106.5 milliequivalents per liter of chloride, 35 milliequivalents per liter of bicarbonate and 4 milliequivalents per liter of sodium acetate. The concentration of each may be vary up or down in custom prepared solutions. Most manufac¬ turers supply a series of hemodialysis solutions which have varying concentrations of the chemical species there- within.
The advantages of the invention may be achieved such that any of the commercially available, standard hemo¬ dialysis solutions or custom hemodialysis solutions may be produce . The invention involves providing sufficient sodium chloride in a bicarbonate concentrate such that the concentration of sodium chloride in the bicar¬ bonate concentration is at least 28 grams per liter. The higher the concentration of sodium chloride in the bicar- bonate concentrate, the lower the sodium chloride con¬ centration is in the acid concentrate. The total amount of sodium chloride in hemodialysis solution prepared from the bactericidal and bacteriostatic bicarbonate and acid con¬ centrates remains unchanged. As the quantity of sodium chloride within the bicarbonate concentrate increases it decreases in the acid concentrate, such that the total amount of sodium chloride in the final hemodialysis solu¬ tion is unchanged.
It has been found that a bicarbonate concentrate of 28.0 grams NaCl per liter will be bacteriostatic. How¬ ever, since such a solution is at the lower limit which will create a bacteriostatic solution, the concentrate should be aged for seven days and tested for growth before use. The concentrate is bacteriostatic after aging for about one week. There is a possibility of bacterial growth before the seven days have elapsed at the marginally bacterio¬ static concentration.
Preferably, the concentration of NaCl is grams per liter in the bicarbonate concentrate is about 35.3 or higher. The higher concentrations of salt have even greater bacteriostatic properties. The concentration of NaCl is limited by its solubility characteristics when in solution with sodium bicarbonate. At temperature ranges in which the concentrate will probably be used in forming dialysis solution the maximum concentration of NaCl would be about 200 grams/liter.
The normal concentration of bicarbonate in a human body is about 20 milliequivalents (meq.) per liter. Hemodialysis usually involves a solution having about 39 meq. bicarbonate per liter. However, in some applications, the dialysis may involve 20 to as low as 15 meq. bicar¬ bonate per liter. The maximum sodium bicarbonate in the bicarbonate concentrate would be about 164 grams/liter if the concentrate is prepared at an elevated temperature. The concentration of sodium chloride in the acid concentrate depends on the concentration of sodium chloride in the bicarbonate concentrate. The maximum sodium chloride concentration in the acid concentrate is limited by the necessity of maintaining at least 28 grams per liter of sodium chloride in the bicarbonate concentrate. The concentration of sodium chloride in the acid concentrate may be zero, with all of the sodium chloride being present in the bicarbonate concentrate. Example 1 (A) Acid Concentrate Grams per Liter
Sodium Chloride 118.4
Calcium Chloride 9.5
Potassium Chloride 5.5
Magnesium Chloride 3.7 Acetic Acid 8.8
Dextrose 73.7 (B) Bicarbonate Concentrate Grams per Liter Sodium Chloride 52.9
Sodium Bicarbonate 66.0
In order to make up 36.83 liters of prepared hemodialysis solution, acid concentrate and bicarbonate concentrate were prepared to the above concentrations. The bicarbonate concentrate consisted of 96.8 grams NaCl and 120.6 grams of sodium bicarbonate diluted to 1.83 liters with water. The acid concentrate was prepared by adding 118.4 grams NaCl, 9.5 grams calcium chloride, 5.5 grams potassium chloride, 3.7 grams magnesium chloride, 8.8 grams acetic acid and 73.7 grams dextrose to water to a total of 1.0 liter. Both the acid concentrate and bicarbonate con¬ centrate prepared as detailed above are bacteriostatic. Dialysis solution is prepared by adding 34.83 liters of water, 1.83 liters of bicarbonate concentrate and 1.0 liters of acid concentrate together. The bicarbonate and/or acid concentrates may be prepared from the raw powder constitutes singly or more preferably from prepackaged containers which, when diluted as indicated on the label, will yield the bacteriostatic concentrates of the invention. In considering this invention it should be remembered that the present disclosure is illustrative- only, and that the scope of the invention is determined by the appended claims.

Claims

WHAT IS CLAIMED IS:
1. Bacteriostatic animal dialysis concentrate comprising: sodium bicarbonate and sodium chloride in water, said sodium chloride having a concentration greater than 23.8 grams per liter.
2. A composition for use in preparing animal dialysis solution from an acid concentrate and a bicar¬ bonate concentrate, said bicarbonate concentrate comprising: a) sodium bicarbonate; b) sodium chloride; c) water; and d) the concentration of said sodium chloride being at least 28 grams per liter of water and no greater than 200 grams per liter.
3. A composition of matter adapted for use as a hemodialysis bicarbonate concentrate comprising: sodium chloride and sodium bicarbonate, said sodium chloride being in a quantity sufficient such that upon dilution with water said hemodialysis bicarbonate concentrate is bacterio¬ static.
4. A composition comprising sodium chloride and sodium bicarbonate for use in preparing dialysis bicar¬ bonate concentrate solution, said sodium chloride being in a ratio to said sodium bicarbonate such that upon dilution to obtain a bicarbonate concentrate having the desired bicarbonate concentration, said sodium chloride has a con¬ centration greater than 28 grams per liter.
5. A composition for use in preparing dialysis bicarbonate concentrate, wherein the desired concentration of sodium bicarbonate in the dialysis bicarbonate con¬ centrate is X grams per liter, the composition comprising: sodium bicarbonate and sodium chloride in a ratio of X:Y, Y being the concentration of sodium chloride in the dialysis bicarbonate concentrate and Y being at least 28 and less than about 200.
6. A composition comprising sodium bicarbonate and sodium chloride, expressed in gram ratios as follows: w aHCθ3 : x NaCl wherein "w" is the desired concentration in grams per liter of sodium bicarbonate in a hemodialysis bicarbonate concentrate prepared from said composition and x is a value of greater than 28.
7. A composition for use in preparing dialysis solution from acid concentrate and a bicarbonate con¬ centrate, said acid concentrate comprising: a) sodium chloride; b) calcium chloride; c) potassium chloride; d) magnesium chloride; e) acetic acid; f) dextrose; and g) the concentration of said sodium chloride being less than about 164 grams per liter.
8. A bacteriostatic bicarbonate concentrate composi¬ tion for use in preparing hemodialysis solution from an acid concentrate and a bicarbonate concentrate, the bac¬ teriostatic bicarbonate concentrate comprising: a) sodium chloride; b) sodium bicarbonate; and c) water, said sodium bicarbonate being at a concentration of between about 50 and about 164 grams per liter, and said sodium chloride being at a concentration of between about 28 and about 200 grams per liter.
9. Combinable aqueous bacteriostatic concentrates for forming upon silution dialysis solution for using in human dialysis comprising: a) an acid concentrate including calcium chloride, potassium chloride, magnesium chloride; acetic acid, dextrose and sodium chloride; b) bicarbonate concentrate including sodium bicarbonate and sodium chloride, said sodium chloride being at a concentration of at least 28 grams per liter, the maxium sodium chloride concentration being about 200 grams per liter.
10. A bacteriostatic bicarbonate concentrate for use in preparing dialysis solution for use in dialyzing ani¬ mals, said dialysis solution having between about 80 to about 120 milliequivalents each of sodium and chloride derived from sodium bicarbonate, said bicarbonate con¬ centrate comprising: a) all of the sodium bicarbonate required to yield 15-45 milliequivalents of bicarbonate in the dialysis solution; and b) sodium chloride in an amount equal to or greater than 28 grams per liter up to all of the sodium and chloride derived from sodium chloride in the dialysis solution.
11. A composition for use in preparing a bac¬ teriostatic bicarbonate concentrate for use in preparing hemodialysis solution, said composition comprising: a) sodium chloride; b) sodium bicarbonate; and c) said sodium chloride being in a quantity such that upon dilution with water to yield a sodium bicar¬ bonate concentration of between about 50 and 164 grams per liter, said sodium chloride concentration will be at least 28 grams per liter and less than about 200 grams per liter.
PCT/US1985/002375 1984-12-06 1985-12-03 Bacteriostatic hemodialysis concentrate WO1986003407A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
NO1986863089A NO863089D0 (en) 1984-12-06 1986-07-31 BACTERIOSTATIC HEMOLYSIS CONCENTRATE.
FI863187A FI863187A0 (en) 1984-12-06 1986-08-05 BACTERIOSTATIC HEMODIALYSIS CONCENTRATES.
DK375586A DK375586A (en) 1984-12-06 1986-08-06 BACTERIOSTATIC HAEMODIALYSIS CONCENTRATE

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US67864184A 1984-12-06 1984-12-06
US678,641 1991-04-01

Publications (1)

Publication Number Publication Date
WO1986003407A1 true WO1986003407A1 (en) 1986-06-19

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ID=24723665

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1985/002375 WO1986003407A1 (en) 1984-12-06 1985-12-03 Bacteriostatic hemodialysis concentrate

Country Status (5)

Country Link
EP (1) EP0208709A1 (en)
AU (1) AU5233286A (en)
FI (1) FI863187A0 (en)
NO (1) NO863089D0 (en)
WO (1) WO1986003407A1 (en)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AT397356B (en) * 1987-12-11 1994-03-25 Kishishita Ryutaro WHEEL MECHANISM FOR A GAME
US6475529B2 (en) 1999-09-10 2002-11-05 Baxter International Inc. Bicarbonate-based solution in two parts for peritoneal dialysis or substitution in continuous renal replacement therapy
US7011855B2 (en) 1994-07-01 2006-03-14 Baxter International Inc. Biochemically balanced peritoneal dialysis solutions
US7122210B2 (en) 2002-01-11 2006-10-17 Baxter International Inc. Bicarbonate-based solutions for dialysis therapies
US7445801B2 (en) 2002-06-07 2008-11-04 Baxter International Inc. Stable bicarbonate-based solution in a single container
US9180069B2 (en) 2005-01-28 2015-11-10 Fresenius Medical Care Holdings, Inc. Systems and methods for delivery of peritoneal dialysis (PD) solutions
US9585810B2 (en) 2010-10-14 2017-03-07 Fresenius Medical Care Holdings, Inc. Systems and methods for delivery of peritoneal dialysis (PD) solutions with integrated inter-chamber diffuser

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU627309B2 (en) * 1989-05-26 1992-08-20 Terumo Kabushiki Kaisha Preparation for blood dialysis and method for production thereof
AU627141B3 (en) * 1991-09-13 1992-06-26 Baxter International Inc. Peritoneal dialysis solution

Citations (4)

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Publication number Priority date Publication date Assignee Title
US3821368A (en) * 1971-06-01 1974-06-28 Cybersal Inc Therapeutic composition
US3978212A (en) * 1973-12-19 1976-08-31 Chemo Drug Company Electrolyte solutions containing magnesium and free bicarbonate ions
US3993750A (en) * 1974-12-20 1976-11-23 Research Corporation Aqueous hypertonic solution and compositions useful for preparation of same
US3993751A (en) * 1972-11-27 1976-11-23 Cybersol, Inc. Process for stabilizing therapeutic compositions and article

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3821368A (en) * 1971-06-01 1974-06-28 Cybersal Inc Therapeutic composition
US3993751A (en) * 1972-11-27 1976-11-23 Cybersol, Inc. Process for stabilizing therapeutic compositions and article
US3978212A (en) * 1973-12-19 1976-08-31 Chemo Drug Company Electrolyte solutions containing magnesium and free bicarbonate ions
US3993750A (en) * 1974-12-20 1976-11-23 Research Corporation Aqueous hypertonic solution and compositions useful for preparation of same

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AT397356B (en) * 1987-12-11 1994-03-25 Kishishita Ryutaro WHEEL MECHANISM FOR A GAME
US7011855B2 (en) 1994-07-01 2006-03-14 Baxter International Inc. Biochemically balanced peritoneal dialysis solutions
US6475529B2 (en) 1999-09-10 2002-11-05 Baxter International Inc. Bicarbonate-based solution in two parts for peritoneal dialysis or substitution in continuous renal replacement therapy
US7122210B2 (en) 2002-01-11 2006-10-17 Baxter International Inc. Bicarbonate-based solutions for dialysis therapies
US7445801B2 (en) 2002-06-07 2008-11-04 Baxter International Inc. Stable bicarbonate-based solution in a single container
US9180069B2 (en) 2005-01-28 2015-11-10 Fresenius Medical Care Holdings, Inc. Systems and methods for delivery of peritoneal dialysis (PD) solutions
US9585810B2 (en) 2010-10-14 2017-03-07 Fresenius Medical Care Holdings, Inc. Systems and methods for delivery of peritoneal dialysis (PD) solutions with integrated inter-chamber diffuser
US10842714B2 (en) 2010-10-14 2020-11-24 Fresenius Medical Care Holdings, Inc. Systems and methods for delivery of peritoneal dialysis (PD) solutions with integrated inter chamber diffuser
US11779519B2 (en) 2010-10-14 2023-10-10 Fresenius Medical Care Holdings, Inc. Systems and methods for delivery of peritoneal dialysis (PD) solutions with integrated inter-chamber diffuser

Also Published As

Publication number Publication date
AU5233286A (en) 1986-07-01
NO863089L (en) 1986-07-31
EP0208709A1 (en) 1987-01-21
NO863089D0 (en) 1986-07-31
FI863187A (en) 1986-08-05
FI863187A0 (en) 1986-08-05

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