Method and system for providing peritoneal dialysis fluids with variable potassium concentrations

Patent metadata

Field	Value
Publication number	US-12138280-B2
Application number	US-201816760569-A
Country	US
Kind code	B2
Filing date	Oct 25, 2018
Priority date	Nov 3, 2017
Publication date	Nov 12, 2024
Grant date	Nov 12, 2024

Abstract

Methods and systems are provided for preparing a ready-to-use peritoneal dialysis fluid for peritoneal dialysis of a patient having a deficiency in potassium. The methods comprise mixing, immediately before administration to the patient, appropriate amounts of at least a first concentrate, a second concentrate, and a third concentrate with an appropriate amount of water to form a ready-to-use dialysis fluid. The first concentrate comprises glucose, has a pH of between 1.5 and 4, and is free of potassium ions; the second concentrate comprises a physiologically acceptable buffer and is free of potassium ions; and the third concentrate comprises the physiologically acceptable buffer and potassium ions.

First claim

The invention claimed is:

1. A method for preparing a ready-to-use peritoneal dialysis fluid for peritoneal dialysis of a patient having a deficiency in potassium, the method comprising:
mixing, before administration to the patient, appropriate amounts of at least a first concentrate, a second concentrate, and a third concentrate with an appropriate amount of water to form the ready-to-use peritoneal dialysis fluid,
wherein the first concentrate includes glucose, has a pH of between 1.5 and 4.5, and is free of potassium ions,
wherein the second concentrate includes a physiologically acceptable buffer and is free of potassium ions,
wherein the third concentrate includes the physiologically acceptable buffer and potassium ions, and the potassium ions in the third concentrate have a concentration between 0.04 M and 0.1 M, and
wherein the ready-to-use peritoneal dialysis fluid is a dilution of between 1:10 and 1:50 of at least one of the first concentrate, the second concentrate or the third concentrate, and
wherein exclusive of the potassium ions, the third concentrate is the same as the second concentrate.

2. The method of claim 1 , wherein the second concentrate or the third concentrate has a pH of between 5.0 and 9.0.

3. The method of claim 1 , wherein the physiologically acceptable buffer includes one or more selected from the group consisting of: acetate, lactate, citrate, pyruvate, carbonate, bicarbonate, and amino acid buffers.

4. The method of claim 1 , wherein the physiologically acceptable buffer includes one or both of lactate and bicarbonate.

5. The method of claim 1 , wherein the second concentrate or the third concentrate further includes at least one electrolyte selected from the group consisting of sodium, calcium, and magnesium.

6. The method of claim 1 , wherein the water is sterile water produced by reverse osmosis or distillation and sterile filtration.

7. The method of claim 1 , wherein the ready-to-use dialysis fluid has a potassium ion concentration of about 0.1 mM to about 4 mM.

8. The method of claim 1 , wherein the ready-to-use peritoneal dialysis fluid includes:
90 to 140 mM sodium (Na + ),
0.5 to 4 mM potassium (K + ),
0 to 2 mM calcium (Ca 2+ ),
0 to 0.75 mM magnesium (Mg 2+ ),
0 to 40 mM lactate,
0 to 40 mM bicarbonate, and
0 to 5% glucose.

9. The method of claim 1 , wherein the ready-to-use peritoneal dialysis fluid includes:
132 mM sodium (Na + ),
1 to 4 mM potassium (K + ),
0.5 to 2 mM calcium (Ca 2+ ),
0.25 to 0.75 mM magnesium (Mg 2+ ),
0 to 40 mM lactate, and
1 to 5% glucose.

10. The method of claim 1 , wherein the ready-to-use peritoneal dialysis fluid contains 15 mM to 40 mM lactate.

11. The method of claim 1 , wherein the first concentrate includes an acid selected from HCl and organic acids.

12. The method of claim 1 , wherein the ready-to-use peritoneal dialysis fluid is adapted for automated peritoneal dialysis.

13. The method of claim 1 , wherein the first concentrate includes 25 to 60% glucose.

14. The method of claim 1 , wherein the second concentrate includes:
1.0 to 5.5 M sodium (Na + ),
0 to 0.15 M calcium (Ca 2+ ),
0 to 0.03 M magnesium (Mg 2+ ),
0 to 1.60 M lactate, and
0 to 1.60 M bicarbonate.

15. The method of claim 1 , wherein the third concentrate includes:
1.0 to 5.5 M sodium (Na + ),
0 to 0.15 M calcium (Ca 2+ ),
0 to 0.03 M magnesium (Mg 2+ ),
0 to 1.6 M lactate, and
0 to 1.6 M bicarbonate.

16. The method of claim 1 , wherein the ready-to-use peritoneal dialysis fluid is prepared using a system including:
a proportioning device;
at least one source of water adapted for operation with the proportioning device;
at least one source of the first concentrate adapted for operation with the proportioning device;
at least one source of the second concentrate adapted for operation with the proportioning device; and
at least one source of the third concentrate adapted for operation with the proportioning device.

17. The method of claim 16 , wherein the proportioning device includes a controller programmed to cause the proportioning device to perform multiple fills using the ready-to-use dialysis fluid as a patient fill solution, wherein the controller is programmed to effect at least one from the group consisting of: (i) the patient fill solutions of each fill contain the third concentrate, (ii) the patient fill solutions of less than all fills contain the third concentrate, (iii) the patient fill solutions of each fill contain an amount or concentration of the third concentrate, and (iv) one or more or all of the patient fill solutions of the multiple fills contain a different amount or concentration of the third concentrate.

18. The method of claim 1 , wherein the mixing occurs immediately before administration to the patient.

19. A method for preparing a ready-to-use peritoneal dialysis fluid for peritoneal dialysis of a patient having a deficiency in potassium, the method comprising:
mixing, before administration to the patient, appropriate amounts of at least a first concentrate, a second concentrate, and a third concentrate, with an appropriate amount of water, to form the ready-to-use peritoneal dialysis fluid,
wherein the first concentrate is free of potassium ions,
wherein the second concentrate is free of potassium ions,
wherein the third concentrate comprises potassium ions, and the potassium ions in the third concentrate have a concentration between 0.04 M and 0.1 M, and
wherein the ready-to-use peritoneal dialysis fluid is a dilution of between 1:10 and 1:50 of at least one of the first concentrate, the second concentrate or the third concentrate, and
wherein exclusive of the potassium ions, the third concentrate is the same as the second concentrate.

20. The method of claim 19 , wherein the ready-to-use peritoneal dialysis fluid includes 0.1 to 4 mM potassium.

21. The method of claim 19 , wherein the mixing occurs immediately before administration to the patient.

22. A peritoneal dialysis system for administering a peritoneal dialysis fluid to a patient having a deficiency in potassium, the system comprising:
a proportioning device;
at least one source of water adapted for operation with the proportioning device;
at least one source of the first concentrate adapted for operation with the proportioning device, wherein the first concentrate includes glucose, is free of potassium ions, and has a pH of 1.5 to 4.5;
at least one source of the second concentrate adapted for operation with the proportioning device, wherein the second concentrate includes a physiologically acceptable buffer and is free of potassium ions; and
at least one source of the third concentrate adapted for operation with the proportioning device, wherein the third concentrate includes a physiologically acceptable buffer and potassium ions, and the potassium ions in the third concentrate have a concentration between 0.04 M and 0.1 M,
wherein the peritoneal dialysis fluid is a dilution of between 1:10 and 1:50 of at least one of the first concentrate, the second concentrate or the third concentrate, and
wherein exclusive of the potassium ions, the third concentrate is the same as the second concentrate.

23. The method of claim 1 , wherein both the second concentrate and the third concentrate are free of glucose.

24. The method of claim 23 , wherein the first concentrate is free of sodium.

Assignees

• Gambro Lundia Ab

Inventors

• Wieslander Anders
• Jansson Olof
• Wellings Anders

Classifications

• A61M1/287

  Dialysates therefor · CPC title

• A61K9/08 Primary

  Solutions {(composition of solutions A61K47/00)} · CPC title

• A61K31/7004

  Monosaccharides having only carbon, hydrogen and oxygen atoms · CPC title

• A61K33/14

  Alkali metal chlorides; Alkaline earth metal chlorides · CPC title

• A61K33/06

  Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay} · CPC title