System for proportioning fluids

Patent metadata

Field	Value
Publication number	US-10894119-B2
Application number	US-201716095088-A
Country	US
Kind code	B2
Filing date	May 5, 2017
Priority date	May 6, 2016
Publication date	Jan 19, 2021
Grant date	Jan 19, 2021

Abstract

The present invention concerns a system for preparing a ready-to-use peritoneal dialysis fluid. The system comprises a) a proportioning device; b) at least one source of water; c) at least one source of first concentrate adapted for connection with a) and b), d) at least one source of second concentrate adapted for connection with a) and b), and optionally, e) at least one source of further concentrate adapted for connection with a) and b), wherein the first concentrate comprises glucose and has a pH of between 1.5 and 4, and wherein the second concentrate comprises a physiologically acceptable buffer and has a pH of between 5.5 and 9.0.

First claim

The invention claimed is:

1. A system for preparing a ready-to-use peritoneal dialysis fluid, the system comprising;
a proportioning device connectable to a source of water;
at least one source of first concentrate connectable to the proportioning device;
at least one source of second concentrate connectable to the proportioning device; and optionally,
at least one source of further concentrate connectable to the proportioning device,
wherein said first concentrate comprises glucose at a concentration of 1.5 to 4 M and hydrochloric acid and has a pH of between 1.5 and 4, and wherein the first concentrate is free of buffer selected from acetate, lactate, citrate, pyruvate, carbonate, bicarbonate, and amino acid buffer, and free of electrolyte selected from sodium and potassium, and wherein the first concentrate is formulated for dilution with water at a ratio of 1:10 to 1:33; and
wherein said second concentrate comprises a physiologically acceptable buffer which has a pH of between 5.5 and 9.0.

2. A system according to claim 1 , wherein the first concentrate has a pH of between 2.0 and 3.5.

3. A system according to claim 1 , wherein the first concentrate has a pH of between 2.2 and 3.0.

4. A system according to claim 1 , wherein the second concentrate has a pH of between 6.0 and 8.5.

5. A system according to claim 1 , wherein the physiologically acceptable buffer is selected from the group consisting of acetate, lactate, citrate, pyruvate, carbonate, bicarbonate, amino acid buffer, and mixtures thereof.

6. A system according to claim 1 , wherein the physiologically acceptable buffer is lactate, bicarbonate or a mixture thereof.

7. A system according to claim 1 , wherein the first concentrate further comprises at least one electrolyte selected from the group consisting of calcium, and magnesium.

8. A system according to claim 1 , wherein the second concentrate further comprises at least one electrolyte selected from the group consisting of sodium, calcium, magnesium and potassium.

9. A system according to claim 1 , wherein the system comprises at least one source of further concentrate, and wherein the further concentrate comprises at least one electrolyte selected from the group consisting of sodium, calcium, magnesium and potassium.

10. A system according to claim 1 , wherein the further concentrate comprises a physiologically acceptable buffer selected from the group consisting of acetate, lactate, citrate, pyruvate, carbonate, bicarbonate, amino acid buffer, and mixtures thereof.

11. A system according to claim 1 , wherein the first concentrate and the second concentrate each comprises calcium and the second concentrate comprises at least one further electrolyte selected from the group consisting of sodium, magnesium and potassium.

12. A system according to claim 1 , wherein the second concentrate and the further concentrate each comprises calcium and at least one further electrolyte selected from the group consisting of sodium, magnesium and potassium.

13. A system according to claim 1 , wherein the first concentrate and the second concentrate each comprises calcium and the second concentrate comprises at least one further electrolyte selected from the group consisting of sodium, magnesium and potassium, and wherein optionally the further concentrate comprises at least one electrolyte selected from the group consisting of sodium, calcium, magnesium and potassium.

14. A system according to claim 1 , wherein the first concentrate and/or said second concentrate and/or said further concentrate are terminal sterilized.

15. A system according to claim 1 , wherein the second concentrate is configured to be used for dilutions of between 1:10 and 1:40.

16. A system according to claim 1 , wherein the second concentrate is configured to be used for dilutions of between 1:10 and 1:33.

17. A system according to claim 1 , wherein the ready to use peritoneal dialysis fluid contains:
sodium (Na + ) 100-140 mM;
potassium (K + ) 0-4 mM;
calcium (Ca 2+ ) 0-2 mM;
magnesium (Mg 2+ ) 0-0.75 mM;
lactate 0-40 mM;
bicarbonate 0-35 mM; and
glucose 0-5%.

18. A system according to claim 1 , wherein
optionally at least one of the first and second concentrate is terminal sterilized, and wherein the system is constructed to admix the first and second concentrates to form a ready to use peritoneal dialysis solution containing:
sodium (Na + ) 100-140 mM;
potassium (K + ) 0-4 mM;
calcium (Ca 2+ ) 0-2 mM;
magnesium (Mg 2+ ) 0-0.75 mM;
lactate 0-40 mM; and
glucose 0-5%.

19. A system according to claim 18 , wherein the ready to use peritoneal dialysis solution contains:
sodium (Na + ) 132 mM;
potassium (K + ) 0-4 mM;
calcium (Ca 2+ ) 0.5-2 mM;
magnesium (Mg 2+ ) 0.25-0.50 mM;
lactate 0-40 mM; and
glucose 1.5-5%.

20. A system according to claim 19 , wherein the ready to use peritoneal dialysis solution contains:
sodium (Na + ) 132 mM;
potassium (K + ) 0-4 mM;
calcium (Ca 2+ ) 1.25-1.75 mM;
magnesium (Mg 2+ ) 0.25-0.50 mM;
lactate 0-40 mM; and
glucose 1.5-5%.

21. A system according to claim 18 , wherein the ready to use peritoneal dialysis solution comprises no lactate.

22. A system according to claim 18 , wherein the ready to use peritoneal dialysis solution comprises 30 mM lactate.

23. A system according to claim 18 , wherein the ready to use peritoneal dialysis solution comprises 40 mM lactate.

24. A system according to claim 1 , wherein the first concentrate a pH less than 3.2.

25. A system according to claim 1 , wherein said first concentrate has a conductivity of more than 100 μS/cm and a pH of between 1.5 and 3.

26. A system according to claim 1 , wherein the first concentrate has a conductivity of more than 400 μS/cm and a pH of 2.3.

27. A system according to claim 1 ,
wherein the first concentrate has a pH of between 2.4 and 2.8, and
wherein the second concentrate comprises lactate, calcium, citrate, and optionally one or more electrolytes selected from the group consisting of sodium, magnesium, and potassium,
wherein the citrate is present in an amount giving stabilizing effect, and wherein the second concentrate has a pH of between 6.0 and 8.5.

28. A system according to claim 27 , wherein the concentration of citrate is up to 10 mM.

29. A system according to claim 27 , wherein the concentration of citrate is between 0.01 to 10 mM.

Assignees

• Gambro Lundia Ab

Inventors

• Wieslander Anders
• Jansson Olof
• Carlsson Ola
• Hobro Sture
• Sandin Karin
• Enarsson Simon

Classifications

• A61M2202/0488

  Surfactant, e.g. for the lung · CPC title

• A61K33/20

  Elemental chlorine; Inorganic compounds releasing chlorine · CPC title

• A61K31/19

  Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60) · CPC title

• A61K31/194

  having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid · CPC title

• A61K33/14

  Alkali metal chlorides; Alkaline earth metal chlorides · CPC title