Method for the preparation of hemodialysis fluids containing bicarbonate

• US 5,616,248 A
• Filed: 07/08/1993
• Issued: 04/01/1997
• Est. Priority Date: 04/06/1992
• Status: Expired due to Term

• Current Assignee: Wilfried Schal
• Original Assignee: Wilfried Schal
• Inventors: Schal, Wilfried
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US08/088,734
• Time in Patent Office: 1,363 Days
• Field of Search: 210/646, 210/647, 210/321.71, 252/1, 514/832
• US Class Current: 210/647
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1657 with centralised supply of dialysate or constituent thereof for more than one dialysis unit
• CPC Class Codes: A61M 1/1666 by dissolving solids
• CPC Class Codes: A61M 2202/066 made from a compacted product by abrading

Abstract

In the method for the preparation of bicarbonate-containing hemodialysis fluids of individually adaptable compositions according to specific therapeutic requirements of patients a combination of a quantitatively greatly predominating basic concentrate of uniform standard composition is applied in conjunction with an individually selected additional or individual concentrate. The basic concentrate, mainly consisting of sodium chloride and sodium bicarbonate, supplies to the dialysis fluid a sodium concentration at or slightly below the lower limit of the physiological range, whereas the individual concentrate supplies the complementary concentration of sodium up to an individually selected physiological level as well as salts of potassium, calcium, and magnesium and also glucose in individually adapted concentrations. The individual concentrate is a 120- to 250-fold liquid concentrate, resulting in an easy to handle quantity of typically one liter for one dialysis treatment.

Claims

1. A method for preparing a bicarbonate hemodialysis fluid adapted to the individual physiological requirements of a patient in need of dialysis, comprising the steps:

i) providing a primary concentrate (a) of fixed concentration and not tailored to the individual physiological requirements of the patient,

ii) providing a plurality of additional concentrates (b) having differing compositions,

iii) selecting a concentrate (b) according to the individual physiological requirements of the patient, and

iv) diluting concentrate (a) and the selected concentrate (b) with water to obtain said hemodialysis fluid;

wherein

primary concentrate (a) supplies sodium ions between 120 and 135 mmol/liter based on the hemodialysis fluid, 100% of the bicarbonate and has a molar ratio of bicarbonate/sodium of 0.3 or less; and

concentrate (b) is a 120 to 250-fold liquid concentrate that supplies additional sodium in an amount up to 25 mmol/l, 0-5 mmol/l potassium, 0.3-2.5 mmol/l calcium and 0-1.2 mmol/l magnesium ions, all concentrations based on said hemodialysis fluid, representing the total quantities of calcium and magnesium ions in the hemodialysis fluid.

2. The method of claim 1, wherein concentrate (b) further comprises glucose in a concentration up to 10 mmol/l.

3. The method of claim 1, wherein concentrate (b) further comprises hydrochloric acid in a concentration up to 4 mmol/l.

4. The method of claim 1, wherein concentrate (a) further comprises acetate ions up to a molar ratio of acetate/sodium of 0.03 and being a 15 to 18-fold liquid concentrate.

5. The method according to claim 1, wherein concentrate (a) consists of two separate liquid components.

6. The method according to claim 1, wherein concentrate (a) is formed from a dry substance in an intermediate step of the dilution process, forming an at least 5-fold liquid concentrate.

7. The method of claim 1, wherein concentrate (a) is formed from a dry substance, the dry substance being dissolved and diluted with water in a proportion corresponding to the final concentration of said hemodialysis fluid.

8. The method of claim 7 or claim 6, wherein the dry substance of concentrate (a) is applied in prefabricated pieces of standardized geometric shape and size, the pieces of dry concentrate being pulverized in a continuous process and the pulverized substance being dissolved in a flowing stream of water.

9. The method of claim 1, wherein concentrate (a) is diluted with water to the final concentration and distributed to several dialysis machines from a central supply system.

10. The method of claim 1, wherein concentrate (b) is continuously dosed into a flowing stream of diluted concentrate (a).

11. The method of claim 1, wherein a solution is formed by continuously dosing concentrate (b) into a flowing stream of water in a predetermined first proportion and concentrate (a) is continuously added to that solution in a predetermined second proportion.

12. The method according to claim 11, wherein concentrate (b) is dosed into the water supply conduit of a hemodialysis machine.

13. The method of claim 1, wherein more than one concentrate (b) is applied in parallel or in a sequence.

14. The method of claim 1, wherein said concentrate (a) supplies at least 90% of the total solute content of said hemodialysis fluid and has a molar ratio of bicarbonate/sodium of 0.27 or less.