Potassium loaded ion-exchange material for use in a dialysate regeneration system

Patent metadata

Field	Value
Publication number	US-9399090-B2
Application number	US-201313757796-A
Country	US
Kind code	B2
Filing date	Feb 2, 2013
Priority date	Dec 10, 2012
Publication date	Jul 26, 2016
Grant date	Jul 26, 2016

Abstract

Systems and methods for managing the potassium concentration of a dialysate fluid during hemodialysis therapy using cation exchange materials that do not release sodium ions.

First claim

What is claimed is:

1. A system for kidney replacement therapy, comprising:
a hemodialysis system having a controlled compliance dialysis circuit, a dialyzer with a dialysis membrane, a blood inlet end for receiving blood, a blood outlet end for allowing blood out of the dialyzer, a dialysate inlet end for receiving dialysate and a dialysate outlet end for allowing dialysate out of the dialyzer, wherein the blood and the dialysate contact different sides of the dialysis membrane;
a dialysate flow loop for circulating a dialysate through a dialyzer where at least one waste species enters the dialysate;
a dialysate regeneration unit containing at least one sorbent material for decreasing the concentration or conductivity of at least one waste species and releasing potassium ions to the dialysate; and
a potassium management system for modifying the potassium ion concentration of the dialysate in the dialysate flow loop, generating a potassium modified fluid, the potassium-modified fluid having a potassium ion concentration or conductivity that is higher or lower than the fluid in the dialysate flow loop; wherein at least a portion of the dialysate is conveyed through the potassium management system; and wherein the potassium management system is positioned downstream of the dialysate regeneration unit; and
a bypass line and a bypass regulator, wherein the bypass line is fluidly connected to the dialysate flow loop downstream of the dialysate regeneration unit and upstream of the potassium management system, and wherein the bypass line bypasses the potassium management system to downstream of the potassium management system;
wherein the potassium management system is an electrodialysis cell comprising at least a concentrate flow channel, a diluate flow channel and an electrode rinse flow channel, wherein potassium ions move from the diluate flow channel to the concentrate flow channel in response to an electric field, wherein the potassium-modified fluid is generated in the diluate flow channel for addition to the dialysate flow loop.

2. The system of claim 1 , further comprising a deionization resin to lower the sodium ion concentration of the dialysate entering the potassium management system.

3. The system of claim 2 , wherein the deionization resin substantially removes sodium ions from the dialysate entering the potassium management system.

4. The system of claim 1 , wherein the potassium management system further comprises a deionization resin to lower the potassium ion concentration from the dialysate.

5. The system of claim 1 , further comprising a control pump connected to an ultrafiltrate reservoir that removes or adds fluid to the dialysate flow loop downstream from the dialyzer, wherein operation of the control pump in an efflux direction causes net removal of fluid from the blood on an extracorporeal side of a membrane in the dialyzer and operation of the control pump in an influx direction causes net addition of fluid to the blood on the extracorporeal side of the membrane.

6. The system of claim 1 , further comprising a potassium ion or conductivity detector that measures the conductivity or potassium ion concentration of the dialysate.

7. The system of claim 1 , wherein the diluate flow channel is defined by a cation exchange membrane and an anion exchange membrane, the concentrate flow channel is defined by a cation exchange membrane and an anion exchange membrane, and an electrode rinse channel is defined by a cation exchange membrane wherein the diluate flow channel is separated from the one or more concentrate flow channel by either a cation or anion exchange membrane.

8. The system of claim 1 , wherein the flow channels are defined in part by a bipolar membrane.

9. The system of claim 1 , further comprising an electrode rinse pump and electrode rinse reservoir for circulating an electrode rinse solution through the electrode rinse flow channel.

10. The system of claim 1 , further comprising a concentrate solution and a concentrate pump for circulating the concentrate solution through the concentrate flow channel and an electrode rinse pump and electrode rinse reservoir for circulating an electrode rinse solution through the electrode rinse flow channel.

11. The system of claim 5 , wherein ultrafiltrate directed toward the ultrafiltrate reservoir passes through the potassium management system prior to collection in the ultrafiltrate reservoir.

12. The system of claim 1 , wherein the dialysate flow loop further comprises a dialysate reservoir located downstream from the dialyzer and upstream from the dialysate regeneration unit.

13. The system of claim 11 , wherein ultrafiltrate passes through the concentrate flow channel prior to collection in the ultrafiltrate reservoir.

14. The system of claim 1 , wherein the potassium-modified fluid has a potassium ion conductivity or concentration less than the dialysate in the dialysate flow loop and thereby capable of reducing the concentration of potassium in the dialysate flow loop upon addition to the dialysate.

15. The system of claim 1 , wherein the potassium management system modifies a conductivity or potassium ion concentration by application of an electrical field.

16. The system of claim 1 , wherein the potassium management system generates the potassium-modified fluid from dialysate removed from the dialysate flow loop.

17. The system of claim 1 , wherein potassium-modified fluid from the potassium management system is added to the dialysate flow loop at a position between an inlet of the dialyzer and an outlet of the dialysate regeneration unit.

18. The system of claim 1 , wherein the potassium management system comprises a capacitive deionization cell.

19. The system of claim 18 , wherein the capacitive deionization cell can store potassium ions for generating a potassium-modified fluid having a higher concentration than the fluid entering the capacitive deionization cell.

20. The system of claim 18 , wherein the potassium management system comprises at least two capacitive deionization cells, wherein one capacitive deionization cell can be regenerated by passing a flushing fluid through the capacitive deionization cell while the other capacitive deionization remains operable to generate the potassium-modified fluid.

21. A method for regenerating a dialysate, comprising:
circulating a dialysate in a dialysate flow loop wherein the dialysate contacts a dialyzer and a dialysate regeneration unit containing at least one sorbent material and a waste species enters the dialysate at the dialyzer and is at least partially removed by the dialysate regeneration unit; and
modifying the potassium concentration of a provided input fluid using a potassium management system to modify the potassium concentration of the dialysate within the dialysate flow loop; wherein the potassium concentration is modified by conveying the dialysate through the potassium management system; and wherein the potassium management system is located downstream of the dialysate regeneration unit;
wherein the dialysate flow loop comprises a bypass line and a bypass regulator, wherein the bypass is fluidly connected to the dialysate flow loop downstream of the dialysate regeneration unit and upstream of the potassium management system, and wherein the bypass line bypasses the potassium management system to downstream of the potassium management system; and
wherein the potassium management system is an electrodialysis cell comprising at least a concentrate flow channel, a dilu

Assignees

• Collier Kenneth J
• Gerber Martin T
• Lura David B
• Meyer Thomas E
• Pudil Bryant J
• Medtronic Inc

Inventors

• Collier Kenneth J
• Gerber Martin T
• Lura David B
• Meyer Thomas E
• Pudil Bryant J

Classifications

• A61M1/1696 Primary

  with dialysate regeneration · CPC title

• A61M1/287

  Dialysates therefor · CPC title

• A61M1/1654

  Dialysates therefor · CPC title

• A61M1/1656 Primary

  Apparatus for preparing dialysates · CPC title

• A61M2205/3317

  Electromagnetic, inductive or dielectric measuring means · CPC title